Unicycive(UNCY) - 2024 Q1 - Quarterly Results

Business Update and Strategic Outlook 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][5] - 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] - Unicycive plans to expand awareness of its programs through presentations at prominent nephrology meetings, including NKF Spring Clinical Meeting and ERA Congress[2][5] CEO's Commentary 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] - 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] - 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] Key Program Highlights 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] - 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] - Enrollment was completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with OLC[12] Oxylanthanum Carbonate (OLC) Program 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] - 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] UNI-494 Program 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] - 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] - 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] Corporate Milestones 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] - 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] Financial Performance for Q1 2024 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][9][10] Statements of Operations Analysis 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] - The increase in G&A expenses was primarily due to an increase in non-cash stock compensation costs[8] Balance Sheet Analysis 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] - The warrant liability increased from $13.1 million to $24.9 million, contributing to the rise in total liabilities[18] Cash Position and Liquidity 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] - A private placement generated $50 million in gross proceeds, significantly bolstering the cash position[12] About Unicycive Therapeutics 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] - OLC is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis[13] - UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury[13] Forward-Looking Statements 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] - 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] - Unicycive specifically disclaims any obligation to update any forward-looking statement[14]