– Oxylanthanum Carbonate (OLC) Topline Data Expected in Q2 2024 –
– UNI-494 Granted Orphan Drug Designation in Delayed Graft Function of Acute Kidney Injury –
– UNI-494 Phase 1 Single Ascending Dose Portion of Clinical Trial Complete –
“The last several months have been extremely productive for Unicycive as we advanced both of our clinical development programs and secured new funding from several leading healthcare institutional investors,” said
“As we close out National Kidney Awareness Month, we remain inspired to continue our research and development efforts to provide improved therapies for individuals living with kidney disease,” concluded
Key Highlights
- 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.
- Completed a private placement with new and existing healthcare institutional investors that generated
$50 million in gross proceeds to Unicycive. - 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 mitochondrial 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.
- Announced that two posters related to OLC will be presented at the
National Kidney Foundation Spring Clinical Meeting taking placeMay 14-18, 2024 , inLong Beach, California . - Announced that multiple presentations will be delivered on OLC and UNI-494 at the 61st
European Renal Association (ERA) Congress taking placeMay 23-26, 2024 , inStockholm, Sweden .
Financial Results for the Year Ended
Licensing Revenues: Licensing revenues for the year ended
Research and Development (R&D) Expenses: R&D expenses for the full year were
General and Administrative (G&A) Expenses: G&A expenses were
Other Income (Expenses): Other income (expenses) increased
Net Loss: Net loss attributable to common stockholders for the year ended
Cash Position: As of
About Unicycive Therapeutics
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
Investor Contact:
ir@unicycive.com
(650) 900-5470
SOURCE:
--Tables to Follow--
Balance Sheets | ||||||||
(in thousands, except for share and per share amounts) | ||||||||
As of | As of | |||||||
2022 | 2023 | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash | $ | 455 | $ | 9,701 | ||||
Prepaid expenses and other current assets | 2,189 | 3,698 | ||||||
Total current assets | 2,644 | 13,399 | ||||||
Right of use asset, net | 152 | 766 | ||||||
Property, plant and equipment, net | 22 | 26 | ||||||
Total assets | $ | 2,818 | $ | 14,191 | ||||
Liabilities and stockholders’ deficit | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 892 | $ | 839 | ||||
Accrued liabilities | 2,237 | 3,234 | ||||||
Warrant liability | - | 13,134 | ||||||
Operating lease liability - current | 155 | 327 | ||||||
Total current liabilities | 3,284 | 17,534 | ||||||
Operating lease liability - long term | - | 466 | ||||||
Total liabilities | 3,284 | 18,000 | ||||||
Commitments and contingencies | ||||||||
Stockholders’ deficit: | ||||||||
Series A-2 preferred stock, | - | - | ||||||
Preferred stock, | - | - | ||||||
Common stock, | 15 | 35 | ||||||
Additional paid-in capital | 33,516 | 60,697 | ||||||
Accumulated deficit | (33,997 | ) | (64,541 | ) | ||||
Total stockholders’ deficit | (466 | ) | (3,809 | ) | ||||
Total liabilities and stockholders’ deficit | $ | 2,818 | $ | 14,191 |
Statements of Operations | ||||||||
(in thousands, except for share and per share amounts) | ||||||||
Year Ended | Year Ended | |||||||
2022 | 2023 | |||||||
Licensing revenues: | $ | 951 | $ | 675 | ||||
Operating expenses: | ||||||||
Research and development | 12,436 | 12,902 | ||||||
General and administrative | 6,567 | 8,547 | ||||||
Total operating expenses | 19,003 | 21,449 | ||||||
Loss from operations | (18,052 | ) | (20,774 | ) | ||||
Other income (expenses): | ||||||||
Interest income | - | 615 | ||||||
Interest expense | (6 | ) | (82 | ) | ||||
Change in fair value of warrant liability | - | (10,303 | ) | |||||
Total other income (expenses) | (6 | ) | (9,770 | ) | ||||
Net loss | (18,058 | ) | (30,544 | ) | ||||
Deemed dividend to Series A-1 preferred stockholders | - | (867 | ) | |||||
Net loss attributable to common stockholders | $ | (18,058 | ) | $ | (31,411 | ) | ||
Net loss per share attributable to common stockholders, basic and diluted | $ | (1.20 | ) | $ | (1.28 | ) | ||
Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 15,057,049 | 24,539,309 |
Source:
2024 GlobeNewswire, Inc., source