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Unicycive(UNCY) - 2024 Q4 - Annual Results
UnicyciveUnicycive(US:UNCY)2025-03-31 20:15

Executive Summary & Business Update Unicycive Therapeutics announced 2024 financial results, highlighting 2025 as transformational with anticipated FDA approval and launch of OLC for hyperphosphatemia Company Overview and Strategic Outlook Unicycive Therapeutics announced 2024 financial results, highlighting 2025 as transformational with anticipated FDA approval and launch of OLC for hyperphosphatemia - Unicycive Therapeutics is a clinical-stage biotechnology company developing therapies for patients with kidney disease1 - Oxylanthanum carbonate (OLC) New Drug Application (NDA) for hyperphosphatemia in CKD patients on dialysis is under review by the FDA1 - The PDUFA target action date for OLC is June 28, 2025, with commercial launch anticipated in late 20251 - CEO Shalabh Gupta, M.D., stated that OLC is positioned to be an important new option for patients with uncontrolled hyperphosphatemia due to its high potency and low pill burden2 Key Highlights & Upcoming Milestones The company achieved significant regulatory and clinical milestones for OLC and UNI-494, while actively developing commercial infrastructure and expanding OLC awareness Oxylanthanum Carbonate (OLC) Development & Regulatory Status The FDA accepted OLC's NDA for hyperphosphatemia with a PDUFA date of June 28, 2025, while a Korean NDA was also submitted by a partner - The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for OLC for the treatment of hyperphosphatemia in patients with CKD on dialysis3 - The FDA set a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 20253 - Unicycive's partner, Lotus Pharmaceutical, submitted an NDA for OLC in the Republic of Korea, with an application decision anticipated in June 20263 - Unicycive has the potential to receive up to $3.7 million in milestone payments and tiered royalties from Lotus Pharmaceutical based on regulatory and commercial achievements3 UNI-494 Development UNI-494 successfully completed its Phase 1 study, demonstrating favorable tolerability and rapid absorption, with data presented at ASN 2024 - Successfully completed Phase 1 study of UNI-494 in healthy volunteers, demonstrating favorable tolerability, fast absorption, and rapid metabolization9 - Data from the Phase 1 study and supportive preclinical data were presented at ASN 2024 and published in EC Pharmacology and Toxicology9 Commercialization and Awareness Efforts The company is establishing commercial infrastructure and expanding OLC awareness through publications and presentations highlighting its safety and efficacy - Continued efforts to establish an efficient commercial infrastructure, including building key functions, engaging with prescribers and stakeholders, and preparing for market access9 - Expanded awareness of OLC through publication of clinical, preclinical, and patient survey data in peer-reviewed journals (Clinical Therapeutics, Clinical and Translational Science, Journal of Nephrological Science) and a late-breaker presentation at ASN Kidney Week 20249 - Published data highlighted OLC's favorable safety and tolerability profile, efficacy in controlling serum phosphate levels, bioequivalence to approved lanthanum carbonate chewable tablets, and potential benefits of combination treatment with tenapanor9 Financial Performance for Full Year 2024 Unicycive Therapeutics reported a net loss of $37.8 million for 2024, an increase from 2023, driven by higher R&D and G&A expenses, but ended the year with $26.1 million in cash Summary of Financial Results Unicycive Therapeutics reported a $37.8 million net loss for 2024, an increase driven by higher drug development costs, ending the year with $26.1 million in cash Key Financials (Year Ended December 31, in thousands) | Metric | 2023 | 2024 | Change (YoY) | | :-------------------------------- | :----- | :----- | :----------- | | Licensing revenues | $675 | $0 | -$675 (100% decrease) | | R&D expenses | $12,902 | $20,014 | +$7,112 (55.1% increase) | | G&A expenses | $8,547 | $12,103 | +$3,556 (41.6% increase) | | Other Income (Expenses) | $(9,770) | $(4,612) | +$5,158 (52.8% improvement) | | Net loss attributable to common stockholders | $(31,411) | $(37,824) | -$6,413 (20.4% increase in loss) | | Net loss per share (basic and diluted) | $(1.28) | $(0.56) | +$0.72 (improved loss per share) | | Cash and cash equivalents (as of Dec 31) | $9,701 | $26,142 | +$16,441 (169.5% increase) | - The increase in research and development expenses was primarily due to an increase in drug development and labor costs5 - The increase in general and administrative expenses was primarily due to an increase in labor, consulting, and professional services costs6 - The increased net loss for the year ended December 31, 2024, was attributable primarily to an increase in drug development costs7 - As of December 31, 2024, cash and cash equivalents totaled $26.1 million, and the Company believes it has sufficient resources to fund planned operations into 20268 Detailed Financial Statements This section presents detailed Balance Sheets and Statements of Operations for 2023 and 2024, providing a breakdown of the company's financial position and performance Balance Sheets The balance sheet shows a significant increase in cash and total assets, with a shift from stockholders' deficit to positive equity in 2024 Balance Sheet Highlights (as of December 31, in thousands) | Metric | 2023 | 2024 | Change (YoY) | | :-------------------------------- | :----- | :----- | :----------- | | Cash | $9,701 | $26,142 | +$16,441 | | Total current assets | $13,399 | $30,948 | +$17,549 | | Total assets | $14,191 | $31,668 | +$17,477 | | Warrant liability | $13,134 | $18,936 | +$5,802 | | Total current liabilities | $17,534 | $24,120 | +$6,586 | | Total liabilities | $18,000 | $24,237 | +$6,237 | | Total stockholders' (deficit) equity | $(3,809) | $7,431 | +$11,240 | | Common stock shares outstanding | 34,756,049 | 113,842,364 | +79,086,315 | - Total assets increased from $14.191 million in 2023 to $31.668 million in 202414 - Total stockholders' equity shifted from a deficit of $(3.809) million in 2023 to a positive $7.431 million in 202414 Statements of Operations The statements of operations reveal a decrease in licensing revenues, a substantial increase in operating expenses, and an improved net loss per share despite a higher net loss Statements of Operations (Year Ended December 31, in thousands) | Metric | 2023 | 2024 | Change (YoY) | | :-------------------------------------------------- | :----- | :----- | :----------- | | Licensing revenues | $675 | $0 | -$675 | | Research and development | $12,902 | $20,014 | +$7,112 | | General and administrative | $8,547 | $12,103 | +$3,556 | | Total operating expenses | $21,449 | $32,117 | +$10,668 | | Loss from operations | $(20,774) | $(32,117) | -$11,343 | | Change in fair value of warrant liability | $(10,303) | $(5,802) | +$4,501 | | Net loss | $(30,544) | $(36,729) | -$6,185 | | Net loss attributable to common stockholders | $(31,411) | $(37,824) | -$6,413 | | Net loss per share, basic and diluted | $(1.28) | $(0.56) | +$0.72 | | Weighted-average shares outstanding | 24,539,309 | 66,985,129 | +42,445,820 | - Licensing revenues decreased to zero in 2024 from $675 thousand in 202316 - Operating expenses increased by 49.7% from $21.449 million in 2023 to $32.117 million in 202416 - Net loss per share improved from $(1.28) in 2023 to $(0.56) in 2024, despite an increased net loss, due to a significant increase in weighted-average shares outstanding16 About Unicycive Therapeutics Unicycive Therapeutics is a biotechnology company focused on developing novel kidney disease treatments, with lead candidate OLC under FDA review and UNI-494 in clinical development Company Profile and Product Pipeline Unicycive Therapeutics develops novel kidney disease treatments, with lead candidate OLC under FDA review and UNI-494 having completed a Phase 1 trial - Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases10 - OLC is the lead drug candidate, an investigational phosphate binding agent for hyperphosphatemia in chronic kidney disease patients on dialysis10 - OLC has positive pivotal trial results (June 2024) and its NDA is under FDA review with a PDUFA Target Action Date of June 28, 202510 - OLC is protected by a strong global patent portfolio, including an issued patent on composition of matter with exclusivity until 2031, and potential extension until 203510 - UNI-494 is a patent-protected new chemical entity in clinical development for acute kidney injury, having successfully completed a Phase 1 trial10 Forward-Looking Statements & Disclaimers This section details Unicycive's forward-looking statements, emphasizing that actual results may differ due to various risks, and the company disclaims any obligation to update them Forward-Looking Statements This section outlines Unicycive's forward-looking statements, emphasizing that actual results may differ due to various risks, and the company disclaims any obligation to update them - Statements in the press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 199511 - Actual results could differ materially due to factors such as lengthy and expensive clinical trials with uncertain outcomes, potential suspension or discontinuation of trials, dependence on third parties for manufacturing, substantial competition, uncertainties of patent protection and litigation, and risks related to FDA clearances or approvals11 - Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise11