Full Press Release Details
Announces Full Year 2023 Financial Results and Provides Business Update
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 -
ALTOS, Calif., March 28, 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 year ended December 31, 2023, and provided a business update.
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 Shalabh Gupta, M.D., Chief Executive Officer of Unicycive.
"The completion of enrollment in our pivotal OLC clinical trial was a critical achievement as we believe the novel characteristics
of oxylanthanum carbonate (OLC) will show its potential as a best-in-class product to treat hyperphosphatemia for patients with chronic
kidney disease (CKD) on dialysis. Positive results from the trial will provide the basis to file a New Drug Application (NDA) with the
U.S. Food and Drug Administration (FDA), and we remain on track with topline data expected from the trial towards the latter part of
the second quarter of this year and plan to file the NDA shortly thereafter."
Gupta, added, "We also made meaningful progress with our second clinical development program, UNI-494, targeting prevention of
delayed graft function (DGF) and other conditions related to acute kidney injury. Earlier this month, UNI-494 was granted orphan drug
designation by the FDA for the prevention of DGF after kidney transplantation, and we presented new data showing statistically significant
results for UNI-494 in a preclinical model of DGF. We successfully completed the single ascending dose (SAD) portion of our Phase 1 clinical
trial, and the multiple ascending dose (MAD) portion of the study is currently ongoing. We expect to complete the Phase 1 trial and report
the full results in the second half of this year."
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 Dr. Gupta.
Results for the Year Ended December 31, 2023
Revenues: Licensing revenues for the year ended December 31, 2023 were $0.7 million compared to $1.0 million for the same period in 2022,
due to an upfront payment for a licensing agreement entered into with Lotus International PTE Ltd in February 2023. We received an upfront
payment of approximately $1.0 million associated with a licensing agreement entered into with Lee's Pharmaceutical (HK) Limited
and Development (R&D) Expenses: R&D expenses for the full year were $12.9 million, compared to $12.4 million for the same period
in 2022. The increase was primarily due to a $0.7 million increase in labor costs. Non-cash stock compensation increased $0.5 million.
The increases were partially offset by a decrease in drug development costs of $0.7 million.
and Administrative (G&A) Expenses: G&A expenses were $8.5 million, compared to $6.6 million for the same period in 2022. This
increase was primarily due to an increase of $1.4 million in professional services costs. Labor costs increased $0.5 million, and other
administrative costs increased $0.3 million. Non-cash stock compensation costs increased $0.3 million. The increases were partially offset
by a decrease in insurance expense of $0.5 million.
Income (Expenses): Other income (expenses) increased $9.8 million due primarily to a $10.3 million change in fair value of our warrant
liability. The Company earned interest income of $0.6 million on its cash balance during the year that was partially offset by a $0.1
million increase in interest expense.
Loss: Net loss attributable to common stockholders for the year ended December 31, 2023 was $31.4 million, or $1.28 per share of common
stock, compared to a net loss of $18.1 million, or $1.20 per share of common stock, for the same period in 2022. This increase was attributable
primarily to the $10.3 million change in fair value of our warrant liability.
Position: As of December 31, 2023, cash and cash equivalents totaled $9.7 million. Subsequent to year end, in March 2024, Unicycive completed
a private placement of preferred stock which generated $50 million in gross proceeds. The Company believes that with the inclusion of
the net proceeds from this offering, it will have sufficient resources to fund planned operations into 2026.
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
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.
Unicycive Therapeutics, Inc.
| Unicycive Therapeutics, Inc. |
| Balance Sheets |
| (in thousands, except for share and per share amounts) |
| As of | As of | |||||||
| December 31, | December 31, | |||||||
| 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, $0.001 par value per share - zero and 43,649 shares authorized at December 31, 2022 and December 31, 2023, respectively; zero and 43,649 shares outstanding at December 31, 2022 and December 31, 2023, respectively | - | - | ||||||
| Preferred stock, $0.001 par value per share - 10,000,000 and 9,926,161 shares authorized at December 31, 2022 and December 31, 2023, respectively; no shares issued and outstanding at December 31, 2022 and 2023 | - | - | ||||||
| Common stock, $0.001 par value per share - 200,000,000 shares authorized at December 31, 2022 and 2023; 15,231,655 shares issued and outstanding at December 31, 2022, and 34,756,049 shares issued and outstanding at December 31, 2023 | 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 |
| Unicycive Therapeutics, Inc. |
| Statements of Operations |
| (in thousands, except for share and per share amounts) |
| Year Ended | Year Ended | |||||||
| December 31, | December 31, | |||||||
| 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 |