Full Press Release Details
Announces First Quarter Financial Results and Provides Business Update
track to initiate clinical bioequivalence study of Renazorb to treat hyperphosphatemia in
healthy volunteers in second quarter 2022
to initiate Phase 1 study for UNI-494 in second half of 2022
ALTOS, Calif., May 12, 2022 -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY),
a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results
for the first quarter ended March 31, 2022 and provided a business update.
the first quarter, we continued to make meaningful progress to advance and expand the clinical development of our lead product candidates.
We are on track to start our pivotal bioequivalence trial of Renazorb this quarter, which will form the basis of our 505(b)(2) New Drug
Application (NDA) filing. We are also looking forward to announcing new pre-clinical data and to initiating the first-in-humans clinical
program for UNI-494, our drug that is focused on mitochondrial biology, in the second half of the year," said Shalabh Gupta,
M.D., Chief Executive Officer. "We are adequately funded into 2023, which is expected to allow us to file our NDA for Renazorb
and to conduct the clinical trial for UNI-494. Moving forward, we have an exciting year ahead and are confident in our talented and dedicated
team's ability to execute our strategy to achieve our ambitious goals to bring these innovative new treatments to patients."
(lanthanum dioxycarbonate)
is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment
of hyperphosphatemia in patients with chronic kidney disease (CKD). Its potential best-in-class profile has meaningful patient adherence
benefits over currently available treatment options as it requires smaller and fewer number of pills per dose and is swallowed instead
is a new chemical entity in late preclinical development with a novel mechanism of action that targets mitochondria. Mitochondrial dysfunction
is implicated in acute and chronic disease pathologies in organ systems with high energy demands like the heart, kidney, liver, and eye.
While Unicycive's initial focus is on acute kidney injury (AKI), UNI-494's novel mitochondrial mechanism may also hold promise
for indications beyond the kidney.
Results for First Quarter Ended 2022
Therapeutics 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.
Unicycive Therapeutics, Inc.
Unicycive Therapeutics, Inc.
(in thousands, except for share and per share
| As of | As of | |||||||
| December 31, | March 31, | |||||||
| 2021 | 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 16,579 | $ | 13,620 | ||||
| Prepaid expenses and other current assets | 1,832 | 1,844 | ||||||
| Total current assets | 18,411 | 15,464 | ||||||
| Right of use asset, net | 305 | 268 | ||||||
| Property, plant and equipment, net | 28 | 28 | ||||||
| Total assets | $ | 18,744 | $ | 15,760 | ||||
| Liabilities and stockholders' (deficit) equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 742 | $ | 589 | ||||
| Accrued liabilities | 1,212 | 1,658 | ||||||
| Operating lease liability - current | 151 | 155 | ||||||
| Total current liabilities | 2,105 | 2,402 | ||||||
| Operating lease liability - long term | 155 | 114 | ||||||
| Total liabilities | 2,260 | 2,516 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' (deficit) equity: | ||||||||
| Preferred stock: $0.001 par value per share-10,000,000 shares authorized at December 31, 2021 and March 31, 2022; no shares issued and outstanding at December 31, 2020 and March 31, 2021 | $ | - | $ | - | ||||
| Common stock, $0.001 par value per share - 200,000,000 shares authorized at December 31, 2021 and March 31, 2022; 14,996,534 shares issued and outstanding at December 31, 2021, and 15,020,517 shares issued and outstanding at March 31, 2022 | 15 | 15 | ||||||
| Additional paid-in capital | 32,408 | 32,705 | ||||||
| Accumulated deficit | (15,939 | ) | (19,476 | ) | ||||
| Total stockholders' (deficit) equity | 16,484 | 13,244 | ||||||
| Total liabilities and stockholders' (deficit) equity | $ | 18,744 | $ | 15,760 |
Unicycive Therapeutics, Inc.
Statements of Operations
(in thousands, except for share and per share
| Three Months Ended March 31, | ||||||||
| 2021 | 2022 | |||||||
| Operating expenses: | ||||||||
| Research and development | $ | 450 | $ | 1,933 | ||||
| General and administrative | 281 | 1,604 | ||||||
| Total operating expenses | 731 | 3,537 | ||||||
| Loss from operations | (731 | ) | (3,537 | ) | ||||
| Other expenses: | ||||||||
| Interest expense | (252 | ) | - | |||||
| Gain on extinguishment of debt | 19 | - | ||||||
| Total other expenses | (233 | ) | - | |||||
| Net loss | $ | (964 | ) | $ | (3,537 | ) | ||
| Net loss per share, basic and diluted | $ | (0.11 | ) | $ | (0.24 | ) | ||
| Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 8,576,422 | 15,004,617 |