Full Press Release Details
Third Quarter 2024 Financial Results and Provides Business Update
OLC New Drug Application (NDA) Accepted by the FDA with a PDUFA Target Action Date of June 28, 2025-
Commercial Planning in Progress for 2025 Launch -
Late Breaker Poster Presentation on OLC at ASN Kidney Week -
Successful Completion of UNI-494 Phase 1 Trial -
LOS ALTOS, Calif., November
13, 2024 - 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 September 30, 2024, and provided a business update.
with the tremendous progress we have made over the last several months highlighted by the acceptance of our New Drug Application for oxylanthanum
carbonate (OLC) which may result in the potential approval of our first drug in 2025," said Shalabh Gupta, M.D., Chief Executive
Officer of Unicycive. "If approved, we believe OLC's high potency and low pill burden would provide a best-in-class option
for patients with chronic kidney disease (CKD) on dialysis who have hyperphosphatemia and face adherence challenges with current treatment
regimens. With the NDA acceptance now behind us, we are actively preparing to commercialize OLC with the goal of bringing this innovative
new treatment to market in the second half of 2025."
progress on our second asset, UNI-494, as we announced the successful completion of our Phase 1 clinical trial providing the necessary
data to potentially advance to Phase 2 clinical development. UNI-494 is targeting acute kidney injury (AKI), a challenging and often under-treated
disease. We plan to request a meeting with the FDA by the end of this year to continue advancing our clinical development program for
UNI-494," concluded Dr. Gupta.
for the Quarter Ended September 30, 2024
Research and Development (R&D) expenses were
$3.0 million for the three months ended September 30, 2024, compared to $3.4 million for the three months ended September 30, 2023. The
decrease in research and development expenses was primarily due to decreased drug development costs.
General and Administrative (G&A) expenses
were $3.2 million for the three months ended September 30, 2024, compared to $2.6 million for the three months ended September 30, 2023.
The increase was primarily due to increased non-cash stock compensation expense.
Other Income was $2.2 million for the three months
ended September 30, 2024 compared to $1.6 million in the three months ended September 30, 2023, due primarily to a decrease in the fair
value of our warrant liability.
Net loss attributable to common stockholders for
the three months ended September 30, 2024 was $4.1 million, compared to a net loss attributable to common stockholders of $4.4 million,
for the three months ended September 30, 2023. The decreased net loss for the three-month period ended September 30, 2024 was attributable
to a decrease in the fair value of our warrant liability.
As of September 30, 2024, cash and cash equivalents
totaled $32.3 million. The Company believes that it has sufficient resources to fund planned operations into 2026.
About Unicycive Therapeutics
OLC is protected by a strong global patent portfolio
including issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035
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.
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.
SOURCE: Unicycive Therapeutics, Inc.
--Tables to Follow--
Unicycive Therapeutics, Inc.
(In thousands, except for share and per share
| As of | As of | |||||||
| December 31, | September 30, | |||||||
| 2023 | 2024 | |||||||
| Assets | (Unaudited) | |||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 9,701 | $ | 32,347 | ||||
| Prepaid expenses and other current assets | 3,698 | 5,394 | ||||||
| Total current assets | 13,399 | 37,741 | ||||||
| Right of use asset, net | 766 | 772 | ||||||
| Property, plant and equipment, net | 26 | 61 | ||||||
| Total assets | $ | 14,191 | $ | 38,574 | ||||
| Liabilities and stockholders' (deficit) equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 839 | $ | 548 | ||||
| Accrued liabilities | 3,234 | 2,992 | ||||||
| Warrant liability | 13,134 | 6,377 | ||||||
| Operating lease liability - current | 327 | 542 | ||||||
| Total current liabilities | 17,534 | 10,459 | ||||||
| Operating lease liability - long term | 466 | 265 | ||||||
| Total liabilities | 18,000 | 10,724 | ||||||
| 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 September 30, 2024; 43,649 Series A-2 shares outstanding at December 31, 2023 and 11,111.24 Series A-2 Prime shares outstanding at September 30, 2024 | - | - | ||||||
| Series B-2 preferred stock, $0.001 par value per share - zero Series B-2 shares authorized at December 31, 2023 and 7,882 Series B-2 Prime shares authorized at September 30, 2024; zero Series B-2 shares outstanding at December 31, 2023 and 7,882 Series B-2 shares outstanding at September 30, 2024 | - | - | ||||||
| Preferred stock: $0.001 par value per share-10,000,000 shares authorized at December 31, 2023 and September 30, 2024; zero shares issued and outstanding at December 31, 2023 and September 30, 2024 | - | - | ||||||
| Common stock, $0.001 par value per share - 200,000,000 shares authorized at December 31, 2023 and 400,000,000 shares authorized at September 30, 2024; 34,756,049 and 97,858,406 shares issued and outstanding at December 31, 2023 and September 30, 2024, respectively | 35 | 98 | ||||||
| Additional paid-in capital | 60,697 | 107,497 | ||||||
| Accumulated deficit | (64,541 | ) | (79,745 | ) | ||||
| Total stockholders' (deficit) equity | (3,809 | ) | 27,850 | |||||
| Total liabilities and stockholders' (deficit) equity | $ | 14,191 | $ | 38,574 |
Unicycive Therapeutics, Inc.
Statements of Operations
(In thousands, except for share and per share
| Three Months Ended September 30, | ||||||||
| 2023 | 2024 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 3,372 | $ | 3,045 | ||||
| General and administrative | 2,566 | 3,206 | ||||||
| Total operating expenses | 5,938 | 6,251 | ||||||
| Loss from operations | (5,938 | ) | (6,251 | ) | ||||
| Other income (expenses): | ||||||||
| Interest income | 227 | 416 | ||||||
| Interest expense | (18 | ) | (15 | ) | ||||
| Change in fair value of warrant liability | 1,396 | 1,754 | ||||||
| Total other income (expenses) | 1,605 | 2,155 | ||||||
| Net loss | (4,333 | ) | (4,096 | ) | ||||
| Deemed dividends to Series A-1 preferred stockholders | (72 | ) | - | |||||
| Net loss attributable to common stockholders | $ | (4,405 | ) | $ | (4,096 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.13 | ) | $ | (0.05 | ) | ||
| Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 32,633,074 | 88,943,212 |