Full Press Release Details
Therapeutics Announces Second Quarter 2021 Financial Results
Completed initial public offering in July 2021
with gross proceeds of $25 million
Planned meeting with the U.S. FDA in Q4 2021
to align on Renazorb program
LOS ALTOS, Calif., August
16, 2021 -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology
company developing therapies for patients with kidney disease, today reported financial results for the second quarter ended June
"With our recent initial public offering, we believe we are now
well positioned to advance our pipeline programs for the treatment of kidney diseases," said Shalabh Gupta, M.D., Chief Executive
Officer. "Our lead program, Renazorb, is looking to address the challenging treatment burden faced by patients suffering from hyperphosphatemia
as a result of their chronic kidney disease. Our preclinical studies are ongoing to support an expedited 505(b)(2) regulatory approval
pathway with the U.S. Food and Drug Administration (FDA). We are also advancing UNI-494, our novel
small-molecule mitochondrial protectant product candidate for the potential treatment of acute kidney injury and chronic kidney disease,
through preclinical studies to support our planned investigational new drug application with the FDA next year.
With the recent funding, we look forward to accomplishing
numerous milestones for our key programs."
Key Highlights and Upcoming Milestones
Second Quarter 2021 Financial Results
Research and development expenses for the second
quarter of 2021 were $0.5 million, compared to $0.2 million for the second quarter of 2020. This increase was primarily attributable to
stock compensation expense recorded in the current period.
General and administrative expenses for the second
quarter of 2021 were $0.3 million, compared to $0.2 million for the second quarter of 2020. This increase was primarily attributable to
increases in accounting and professional services costs in the current period.
Net loss for the second quarter of 2021 was $1.1
million, or $0.13 per share of common stock, compared to a net loss of $0.3 million, or $0.04 per share of common stock, for the second
quarter of 2020. This increase was primarily attributable to interest expense and stock compensation expense in the current period.
Unicycive is a biotechnology company developing
novel treatments for kidney diseases. Unicycive's lead drug, Renazorb, is a novel phosphate binding agent being developed for the
treatment of hyperphosphatemia. UNI-494 is a patent protected new chemical entity in late preclinical development for the treatment of
acute kidney injury. For more information, please visit www.unicycive.com.
Forward-looking statement
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
by the use of 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 a number of 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 pre-clinical studies 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, including the outbreak of
COVID-19 coronavirus, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government
or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; 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. There are no guarantees that any of our technology or product candidates will be utilized or prove
to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that
any therapeutics will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the
risk factors set forth in our Form 10-Q for the quarter ended June 30, 2021 and in our registration statement on Form S-1 and other periodic
reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such
list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant
additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date
hereof, and Unicycive does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.
Unicycive Therapeutics, Inc.
(in thousands, except for share and per share
| As of | As of | |||||||
| December 31, | June 30, | |||||||
| 2020 | 2021 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | - | $ | 1 | ||||
| Prepaid related party service fee | - | 38 | ||||||
| Deferred offering costs | 200 | 864 | ||||||
| Prepaid expenses and other current assets | 4 | 10 | ||||||
| Total current assets | 204 | 913 | ||||||
| Total assets | $ | 204 | $ | 913 | ||||
| Liabilities and stockholders' deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 184 | $ | 357 | ||||
| Related party service fee payable | 9 | - | ||||||
| Accrued liabilities | 168 | 658 | ||||||
| Convertible notes | 1,528 | 3,199 | ||||||
| Loan from stockholder | 967 | 901 | ||||||
| Government loan | 19 | - | ||||||
| Total current liabilities | 2,875 | 5,115 | ||||||
| Total liabilities | 2,875 | 5,115 | ||||||
| Commitments and contingencies (Note 7) | ||||||||
| Stockholders' deficit: | ||||||||
| Preferred stock: $0.001 par value per share-10,000,000 shares authorized at December 31, 2020 and June 30, 2021 (unaudited); no shares issued and outstanding at December 31, 2020 and June 30, 2021 (unaudited) | $ | - | $ | - | ||||
| Common stock, $0.001 par value per share - 200,000,000 shares authorized at December 31, 2020 and June 30, 2021 (unaudited); 8,514,070 shares issued and outstanding at December 31, 2020, and 8,771,290 shares issued and outstanding at June 30, 2021 (unaudited) | 9 | 9 | ||||||
| Additional paid-in capital | 3,242 | 3,775 | ||||||
| Accumulated deficit | (5,922 | ) | (7,986 | ) | ||||
| Total stockholders' deficit | (2,671 | ) | (4,202 | ) | ||||
| Total liabilities and stockholders' deficit | $ | 204 | $ | 913 |
Unicycive Therapeutics, Inc.
Statements of Operations
(in thousands, except for share and per share
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2020 | 2021 | 2020 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 182 | $ | 493 | $ | 329 | $ | 942 | ||||||||
| General and administrative | 154 | 286 | 349 | 568 | ||||||||||||
| Total operating expenses | 336 | 779 | 678 | 1,510 | ||||||||||||
| Loss from operations | (336 | ) | (779 | ) | (678 | ) | (1,510 | ) | ||||||||
| Other expenses: | ||||||||||||||||
| Interest expense | (2 | ) | (321 | ) | (4 | ) | (573 | ) | ||||||||
| Gain on extinguishment of debt | - | - | - | 19 | ||||||||||||
| Total other expenses | (2 | ) | (321 | ) | (4 | ) | (554 | ) | ||||||||
| Net loss | $ | (338 | ) | $ | (1,100 | ) | $ | (682 | ) | $ | (2,064 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.04 | ) | $ | (0.13 | ) | $ | (0.08 | ) | $ | (0.24 | ) | ||||
| Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 8,483,382 | 8,771,290 | 8,472,866 | 8,677,497 |
SOURCE: Unicycive Therapeutics, Inc.