Full Press Release Details
Therapeutics Announces Full Year 2024 Financial Results and Provides Business Update
- Oxylanthanum carbonate (OLC) New Drug Application for hyperphosphatemia in chronic kidney disease patients on dialysis under review by the FDA with a PDUFA target action date of June 28, 2025
- Commercial Planning in Preparation for anticipated commercial launch of OLC in late 2025
LOS ALTOS, California, March 31, 2025 -- Unicycive
Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease,
today announced its financial results for the full year ended December 31, 2024, and provided a business update.
"2025 is positioned to be a transformational
year for Unicycive, with the near-term potential for FDA approval and commercial launch of oxylanthanum carbonate (OLC)," said Shalabh
Gupta, M.D., Chief Executive Officer of Unicycive. "For approximately 75% of people in the U.S. with chronic kidney disease (CKD)
on dialysis, hyperphosphatemia remains uncontrolled because of challenges with currently available phosphate binders, potentially increasing
their risk of hospitalization and mortality. If approved, we believe OLC is positioned to be an important new option for these patients,
distinguished by its high potency and a low pill burden. We continue to actively prepare to launch OLC, including educating key stakeholders
on existing OLC data and preparing our commercial infrastructure to rapidly make OLC available to patients upon approval."
Key Highlights & Upcoming Milestones
Financial Results for the Year Ended December
Licensing revenues decreased approximately $0.7
million, from the year ended December 31, 2023 due to an upfront payment of approximately $0.7 million associated with a licensing agreement
entered into with Lotus International Pte Ltd. in February 2023. There was no comparable revenue earned in the current period.
Research and Development (R&D) expenses were
$20.0 million for the year ended December 31, 2024, compared to $12.9 million for the same period in 2023. The increase in research and
development expenses was primarily due to an increase in drug development and labor costs.
General and Administrative (G&A) expenses
were $12.1 million for the year ended December 31, 2024, compared to $8.5 million for the same period in 2023. The increase was primarily
due to an increase in labor, consulting and professional services costs.
Other Income was $4.6 million for the year ended
December 31, 2024 compared to $9.8 million in the same period in 2023 due primarily to a decrease in the fair value of our warrant liability.
Net loss attributable to common stockholders for
the year ended December 31, 2024 was $37.8 million, or $0.56 per share of common stock, compared to a net loss attributable to common
stockholders of $31.4 million, or $1.28 per share of common stock for the same period in 2023. The increased net loss for the year ended
December 31, 2024 was attributable primarily to an increase in drug development costs.
As of December 31, 2024, cash and cash equivalents
totaled $26.1 million. The Company believes that it has sufficient resources to fund planned operations into 2026.
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. Positive
pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration
(FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio
including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035
after OLC approval. Unicycive's second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the
treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. For more information, please
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; our dependence on third parties for manufacturing;
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; market acceptance
of our products; 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, 2024, 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
SOURCE: Unicycive Therapeutics, Inc.
except for share and per share amounts)
| As of | As of | |||||||
| December 31, | December 31, | |||||||
| 2023 | 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 9,701 | $ | 26,142 | ||||
| Prepaid expenses and other current assets | 3,698 | 4,806 | ||||||
| Total current assets | 13,399 | 30,948 | ||||||
| Right of use asset, net | 766 | 645 | ||||||
| Property, plant and equipment, net | 26 | 75 | ||||||
| Total assets | $ | 14,191 | $ | 31,668 | ||||
| Liabilities and stockholders' (deficit) equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 839 | $ | 1,058 | ||||
| Accrued liabilities | 3,234 | 3,562 | ||||||
| Warrant liability | 13,134 | 18,936 | ||||||
| Operating lease liability - current | 327 | 564 | ||||||
| Total current liabilities | 17,534 | 24,120 | ||||||
| Operating lease liability - long term | 466 | 117 | ||||||
| Total liabilities | 18,000 | 24,237 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' (deficit) equity: | ||||||||
| Series A-2 Prime preferred stock, $0.001 par value per share - 43,649 Series A-2 shares authorized at December 31, 2023 and 21,388.01 Series A-2 Prime shares authorized at December 31, 2024; 43,649 Series A-2 shares outstanding at December 31, 2023 and 6,150.21 Series A-2 Prime shares outstanding at December 31, 2024 | - | - | ||||||
| Series B-2 preferred stock, $0.001 par value per share - zero and 7,882 shares authorized at December 31, 2023 and December 31, 2024, respectively; zero and 3,000 shares outstanding at December 31, 2023 and December 31, 2024, respectively | - | - | ||||||
| Preferred stock: $0.001 par value per share-9,926,161 and 9,846,891 shares authorized at December 31, 2023 and December 31, 2024, respectively; zero shares issued and outstanding at December 31, 2023 and December 31, 2024 | - | - | ||||||
| Common stock, $0.001 par value per share - 200,000,000 shares and 400,000,000 shares authorized at December 31, 2023 and December 31, 2024, respectively; 34,756,049 shares issued and outstanding at December 31, 2023, and 113,842,364 shares issued and outstanding at December 31, 2024 | 35 | 114 | ||||||
| Additional paid-in capital | 60,697 | 108,587 | ||||||
| Accumulated deficit | (64,541 | ) | (101,270 | ) | ||||
| Total stockholders' (deficit) equity | (3,809 | ) | 7,431 | |||||
| Total liabilities and stockholders' (deficit) equity | $ | 14,191 | $ | 31,668 |
thousands, except for share and per share amounts)
| Year Ended | Year Ended | |||||||
| December 31, | December 31, | |||||||
| 2023 | 2024 | |||||||
| Licensing revenues | $ | 675 | $ | - | ||||
| Operating expenses: | ||||||||
| Research and development | 12,902 | 20,014 | ||||||
| General and administrative | 8,547 | 12,103 | ||||||
| Total operating expenses | 21,449 | 32,117 | ||||||
| Loss from operations | (20,774 | ) | (32,117 | ) | ||||
| Other income (expenses): | ||||||||
| Interest income | 615 | 1,261 | ||||||
| Interest expense | (82 | ) | (71 | ) | ||||
| Change in fair value of warrant liability | (10,303 | ) | (5,802 | ) | ||||
| Total other income (expenses) | (9,770 | ) | (4,612 | ) | ||||
| Net loss | (30,544 | ) | (36,729 | ) | ||||
| Deemed dividends to Series A-1 preferred stockholders | (867 | ) | - | |||||
| Dividends to Series B-1 preferred stockholders | - | (1,095 | ) | |||||
| Net loss attributable to common stockholders | $ | (31,411 | ) | $ | (37,824 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (1.28 | ) | $ | (0.56 | ) | ||
| Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 24,539,309 | 66,985,129 |