Unicycive Announces First Quarter 2024 Financial Results and Provides Business Update
Unicycive Therapeutics (Nasdaq: UNCY) reported its Q1 2024 financial results and provided a business update.
The pivotal clinical trial for its lead asset, oxylanthanum carbonate (OLC), is on track with topline data expected in Q2 2024. Additionally, OLC and UNI-494 will be featured in multiple presentations at upcoming nephrology conferences. The company has completed enrollment in the pivotal OLC trial. UNI-494, aimed at preventing delayed graft function in kidney transplant patients, has progressed through the multiple ascending dose portion of Phase 1 trials with results expected later this year.
Unicycive was granted orphan drug designation for UNI-494 by the FDA, providing potential benefits such as tax credits and market exclusivity. The company completed a $50 million private placement, bolstering its cash position to $48.9 million as of March 31, 2024. However, the company reported a net loss of $21.2 million for Q1 2024, primarily due to increased R&D and administrative expenses.
- Topline data from the OLC clinical trial expected in Q2 2024.
- Multiple presentations on OLC and UNI-494 at major nephrology meetings.
- Completion of enrollment in the pivotal OLC trial.
- UNI-494 granted orphan drug designation by the FDA.
- Successful $50 million private placement.
- Cash position at $48.9 million as of March 31, 2024, sufficient to fund operations into 2026.
- No licensing revenues for Q1 2024, compared to $0.7 million in Q1 2023.
- R&D expenses increased to $6.8 million, up from $3.0 million in Q1 2023.
- G&A expenses rose to $2.4 million from $1.8 million in Q1 2023.
- Net loss of $21.2 million for Q1 2024, compared to a net loss of $14.8 million in Q1 2023.
- Increase in net loss attributable to higher drug development costs and change in fair value of warrant liability.
Insights
The financial results for Unicycive's first quarter of 2024 reveal some notable shifts. Research and Development (R&D) expenses nearly doubled to
Despite the higher costs and net loss, the company maintains a strong cash position of
Unicycive's progress with their key clinical trials is noteworthy. The pivotal trial for Oxylanthanum Carbonate (OLC) in chronic kidney disease (CKD) patients on dialysis is nearing its topline data release, expected in Q2 2024. This asset has the potential to significantly reduce the pill burden for CKD patients with hyperphosphatemia, which is a common and challenging complication for this patient group. The ability to decrease the pill burden by more than four-fold compared to current treatments would be a substantial advancement, potentially improving patient compliance and quality of life.
Furthermore, UNI-494, targeted at preventing delayed graft function (DGF) post-kidney transplant, has shown promising preclinical data and is advancing through phase 1 clinical trials. The clinical progress of this asset, along with its granted Orphan Drug Designation (ODD), provides financial incentives and market exclusivity if approved, making it a potentially lucrative product for the company. This combination of strong clinical progress and strategic drug designations bodes well for Unicycive's future portfolio.
– On Track to Provide Topline Data from the Ongoing Pivotal Clinical Trial with Oxylanthanum Carbonate (OLC) in Q2 2024 –
– Multiple Presentations on OLC and UNI-494 at Prominent, Upcoming Medical Meetings –
LOS ALTOS, Calif., May 13, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the three months ended March 31, 2024, and provided a business update.
“This is an exciting time for Unicycive as we progress towards the conclusion of our pivotal clinical trial for our lead asset oxylanthanum carbonate (OLC),” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “The trial is evaluating the tolerability, safety, and pharmacokinetics of clinically effective doses of OLC in patients with chronic kidney disease (CKD) on dialysis and it remains on track with topline data expected later this quarter. If approved, OLC may provide a meaningful improvement in the quality of life for CKD patients on dialysis with hyperphosphatemia by reducing the pill burden volume by more than 4-fold compared to the most prescribed phosphate binder1.”
Dr. Gupta, continued, “We are also developing UNI-494 for the prevention of delayed graft function (DGF) after kidney transplantation and other conditions related to acute kidney injury. This is an important indication as DGF is one of the most serious complications resulting from kidney transplantation. UNI-494 is advancing through the multiple ascending dose (MAD) portion of its Phase 1 study, and we expect to complete the trial and report the full results in the second half of this year.”
“A priority for us in 2024 is expanding awareness of our programs within the medical and scientific communities. This month we will be presenting important data on both OLC and UNI-494 at two of the most prominent, global nephrology meetings hosted by the National Kidney Foundation and the European Renal Association. We look forward to providing updates on our programs at these events for all of our stakeholders,” concluded Dr. Gupta.
Key Highlights
- Topline data expected in the second quarter of 2024 from the pivotal clinical trial of OLC in chronic kidney disease (CKD) patients on dialysis with hyperphosphatemia.
- Multiple presentations related to OLC and UNI-494 will be presented at the National Kidney Foundation (NKF) Spring Clinical Meeting (May 14-18) and the 61st European Renal Association (ERA) Congress (May 23-26). Among these presentations, a poster titled “Renal Dietitians Perceive Phosphate Binder and Low Phosphorus Diet Non-Compliance as Top Reasons for Above Target Serum Phosphorus Concentrations”, by lead author Kathleen M. Hill Gallant from the University of Minnesota-Twin Cities was among the top-rated submissions to the NKF Spring Clinical Meeting. The poster reports on the findings from a survey of 100 renal dietitians on factors contributing to patient non-compliance to phosphate binder therapy and the most appealing features of Oxylanthanum Carbonate, if approved.
- Completed enrollment in the open-label, single-arm, multicenter, multidose pivotal clinical trial with OLC, a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed to treat hyperphosphatemia in patients with CKD on dialysis.
- Granted orphan drug designation (ODD) by the FDA to UNI-494 for the prevention of DGF in kidney transplant patients. ODD may provide certain tax credits for qualified clinical trials, exemption of user fees, and the potential for seven years of market exclusivity after approval. UNI-494 is a cytoprotective agent that elicits an ischemic preconditioning effect by activating KATP channels in mitochondria to restore cellular function.
- Presented new data demonstrating statistically significant results for UNI-494 in a preclinical model of DGF at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024. The data provides additional evidence that UNI-494 may be a valuable asset for prevention of DGF and other conditions related to acute kidney injury.
- Successfully completed the single ascending dose (SAD) portion of the Company’s ongoing Phase 1 clinical trial in UNI-494. UNI-494 was well-tolerated up to 160 mg administered as a single dose and was chosen as the go-forward dose based on promising safety, tolerability, and pharmacokinetic data. In the multiple ascending dose (MAD) portion of the study, 80 mg is now being administered twice-a-day to trial participants.
- Completed a private placement with new and existing healthcare institutional investors that generated
$50 million in gross proceeds to Unicycive.
Financial Results for the Quarter Ended March 31, 2024
Licensing Revenues: There were no licensing revenues recorded for the quarter ended March 31, 2024. Licensing revenues of approximately
Research and development (R&D) Expenses: R&D expenses were
General and Administrative (G&A) Expenses: G&A expenses were
Other Income (Expenses): Other income (expenses) was
Net Loss: Net loss attributable to common stockholders for the three months ended March 31, 2024 was
Cash Position: As of March 31, 2024, cash and cash equivalents totaled
About Unicycive Therapeutics
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 follow us on LinkedIn and YouTube.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
1Sprague, et al, “High Phosphate-Binding Capacity of Oxylanthanum Carbonate with a Low Medication Volume: Comparison with Commercially Available Phosphate Binders”, American Journal of Nephrology, September 2023
Investor Contact:
ir@unicycive.com
(650) 900-5470
SOURCE: Unicycive Therapeutics, Inc.
| Unicycive Therapeutics, Inc. | ||||||||
| Balance Sheets | ||||||||
| (In thousands, except for share and per share amounts) | ||||||||
| As of | As of | |||||||
| December 31, | March 31, | |||||||
| 2023 | 2024 | |||||||
| Assets | (Unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,701 | $ | 48,930 | ||||
| Prepaid expenses and other current assets | 3,698 | 2,746 | ||||||
| Total current assets | 13,399 | 51,676 | ||||||
| Right of use asset, net | 766 | 686 | ||||||
| Property, plant and equipment, net | 26 | 23 | ||||||
| Total assets | $ | 14,191 | $ | 52,385 | ||||
| Liabilities, mezzanine equity, and stockholders’ deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 839 | $ | 1,240 | ||||
| Accrued liabilities | 3,234 | 3,550 | ||||||
| Dividends payable | - | 208 | ||||||
| Warrant liability | 13,134 | 24,941 | ||||||
| Operating lease liability - current | 327 | 343 | ||||||
| Total current liabilities | 17,534 | 30,282 | ||||||
| Operating lease liability – long term | 466 | 372 | ||||||
| Total liabilities | 18,000 | 30,654 | ||||||
| Commitments and contingencies (Note 8) | ||||||||
| Mezzanine equity: | ||||||||
| Series B-1 preferred stock, | - | 46,187 | ||||||
| Stockholders’ deficit: | ||||||||
| Series A-2 preferred stock, | - | - | ||||||
| Preferred stock: | - | - | ||||||
| Common stock, | 35 | 37 | ||||||
| Additional paid-in capital | 60,697 | 61,011 | ||||||
| Accumulated deficit | (64,541 | ) | (85,504 | ) | ||||
| Total stockholders’ deficit | (3,809 | ) | (24,456 | ) | ||||
| Total liabilities and stockholders’ deficit | $ | 14,191 | $ | 52,385 | ||||
| Unicycive Therapeutics, Inc. | ||||||||
| Statements of Operations | ||||||||
| (In thousands, except for share and per share amounts) | ||||||||
| (Unaudited) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2023 | 2024 | |||||||
| Licensing revenues: | $ | 675 | $ | - | ||||
| Operating expenses: | ||||||||
| Research and development | 3,030 | 6,813 | ||||||
| General and administrative | 1,847 | 2,391 | ||||||
| Total operating expenses | 4,877 | 9,204 | ||||||
| Loss from operations | (4,202 | ) | (9,204 | ) | ||||
| Other income (expenses): | ||||||||
| Interest income | 14 | 69 | ||||||
| Interest expense | (12 | ) | (20 | ) | ||||
| Change in fair value of warrant liability | (10,375 | ) | (11,808 | ) | ||||
| Total other income (expenses) | (10,373 | ) | (11,759 | ) | ||||
| Net loss | (14,575 | ) | (20,963 | ) | ||||
| Deemed dividend to Series A-1 preferred stockholders | (192 | ) | - | |||||
| Dividend to Series B preferred stockholders | - | (208 | ) | |||||
| Net loss attributable to common stockholders | $ | (14,767 | ) | $ | (21,171 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.97 | ) | $ | (0.61 | ) | ||
| Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 15,232,406 | 34,912,692 | ||||||
FAQ
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