Full Press Release Details
Announces Third Quarter Financial Results and Provides Business Update
results by year-end as enrollment completed for pivotal bioequivalence study of RENAZORB (lanthanum dioxycarbonate), an investigational
phosphate binder for the treatment of hyperphosphatemia in Chronic Kidney Disease (CKD) patients on dialysis
track to file New Drug Application for RENAZORB in 2023
clearance for a Phase 1 healthy volunteer study of UNI-494, a novel proprietary drug targeting the SUR2B subunit of the mitochondrial
KATP channel, in the UK by year-end
ALTOS, Calif., November 14, 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 third quarter ended September 30, 2022, and provided a business update.
third quarter of 2022 and recent weeks have been particularly productive as we completed enrollment of our pivotal bioequivalence trial
of RENAZORB, with topline results expected by year-end. We remain on track to file a New Drug Application (NDA) in 2023," said Shalabh
Gupta, M.D., Chief Executive Officer of Unicycive. "In addition to signing our first global partnership for the marketing and commercialization
of RENAZORB in China with Lee's Pharmaceutical, we continue to make strides in advancing discussions for additional potential partnerships
across Asia and Europe in order to bring the benefits of this exciting new medicine to hyperphosphatemia patients around the globe."
Gupta added, "We were delighted to share favorable results from both our product candidates with the nephrology community at this
year's Kidney Week. The data we presented on RENAZORB demonstrated its ability to effectively reduce urinary phosphate excretion and
underscored the daily pill burden of various phosphate binder therapies, further supporting RENAZORB's potential best-in-class
product profile. In addition, preclinical data on the pharmacokinetics of UNI-494 support its ability to reduce oxidative stress and
restore mitochondrial function in several potential indications."
continue to execute our strategy and remain excited about the opportunities ahead for Unicycive as we advance our clinical studies, expand
access to RENAZORB globally. Additionally, we continue to elucidate UNI-494's novel mechanism to improve mitochondrial function
to treat a variety of diseases with large unmet medical needs and substantial market opportunities," concluded Dr. Gupta.
(lanthanum dioxycarbonate)
is an investigational 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) on dialysis. Its potential best-in-class profile
may have meaningful patient adherence benefits over currently available treatment options as it requires smaller and fewer number of
pills per dose and is swallowed instead of chewed.
is a novel proprietary drug targeting the SUR2B subunit of the mitochondrial KATP channel that reduces oxidative stress and
restores mitochondrial function. UNI-494 is cleaved by esterase enzymes to form nicorandil which is the active metabolite. Nicorandil
has extensive safety and efficacy data from multiple clinical trials including a 5,000-patient randomized controlled trial (IONA Study)
and there is a consensus in the literature that activation of the KATP channel is the biological basis for the observed cardio-protection
and reno-protection in multiple clinical trials.
preclinical studies, UNI-494 showed improvement on the pharmacokinetic profile resulting in substantially higher exposure of nicorandil
that may allow for less frequent and lower dosing.
Unicycive's initial focus is on acute kidney injury (AKI) and chronic kidney disease (CKD), UNI-494's novel mechanism of
action may also hold promise for indications in which mitochondrial dysfunction is implicated such as liver disease (alcoholic hepatitis,
hepatic encephalopathy) and ophthalmic disease (Dry Age-related Macular Degeneration, Glaucoma).
is protected by issued patents in the US and Europe with additional patent applications pending in other jurisdictions.
Results for Third Quarter Ended September 30, 2022
is a registered trademark of Shire Pharmaceutical Group plc (now Takeda Pharmaceutical Company).
thousands, except for share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2022 | 2021 | 2022 | |||||||||||||
| Licensing revenues: | $ | - | $ | 951 | $ | - | $ | 951 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 3,776 | 4,803 | 4,719 | 8,596 | ||||||||||||
| General and administrative | 939 | 1,702 | 1,506 | 5,082 | ||||||||||||
| Total operating expenses | 4,715 | 6,505 | 6,225 | 13,678 | ||||||||||||
| Loss from operations | (4,715 | ) | (5,554 | ) | (6,225 | ) | (12,727 | ) | ||||||||
| Other income (expenses): | ||||||||||||||||
| Interest expense | (55 | ) | (3 | ) | (628 | ) | (3 | ) | ||||||||
| Loss on debt conversion | (431 | ) | - | (431 | ) | - | ||||||||||
| Gain on extinguishment of debt | - | - | 19 | - | ||||||||||||
| Total other income (expenses) | (486 | ) | (3 | ) | (1,040 | ) | (3 | ) | ||||||||
| Net loss | $ | (5,201 | ) | $ | (5,557 | ) | $ | (7,265 | ) | $ | (12,730 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.37 | ) | $ | (0.37 | ) | $ | (0.69 | ) | $ | (0.85 | ) | ||||
| Weighted-average shares outstanding used in computing net loss per share, basic and diluted | 14,167,098 | 15,061,995 | 10,538,473 | 15,050,389 |
thousands, except for share and per share amounts)
| As of | As of | |||||||
| December 31, | September 30, | |||||||
| 2021 | 2022 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 16,579 | $ | 7,010 | ||||
| Prepaid expenses and other current assets | 1,832 | 2,952 | ||||||
| Total current assets | 18,411 | 9,962 | ||||||
| Right of use asset, net | 305 | 191 | ||||||
| Property, plant and equipment, net | 28 | 24 | ||||||
| Total assets | $ | 18,744 | $ | 10,177 | ||||
| Liabilities and stockholders' (deficit) equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 742 | $ | 2,292 | ||||
| Accrued liabilities | 1,212 | 3,065 | ||||||
| Operating lease liability - current | 151 | 165 | ||||||
| Total current liabilities | 2,105 | 5,522 | ||||||
| Operating lease liability - long term | 155 | 29 | ||||||
| Total liabilities | 2,260 | 5,551 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' (deficit) equity: | ||||||||
| Preferred stock: $0.001 par value per share-10,000,000 shares authorized at December 31, 2021 and September 30, 2022; no shares issued and outstanding at December 31, 2021 and September 30, 2022 | $ | - | $ | - | ||||
| Common stock, $0.001 par value per share - 200,000,000 shares authorized at December 31, 2021 and September 30, 2022; 14,996,534 shares issued and outstanding at December 31, 2021, and 15,087,943 shares issued and outstanding at September 30, 2022 | 15 | 15 | ||||||
| Additional paid-in capital | 32,408 | 33,280 | ||||||
| Accumulated deficit | (15,939 | ) | (28,669 | ) | ||||
| Total stockholders' (deficit) equity | 16,484 | 4,626 | ||||||
| Total liabilities and stockholders' (deficit) equity | $ | 18,744 | $ | 10,177 |
Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive's lead drug, RENAZORB (lanthanum
dioxycarbonate), is a novel investigational 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.
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,
including the outbreak of COVID-19 coronavirus, 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, 2021, 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.