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 first quarter ended March 31, 2023 and
provided a business update.
“The first quarter of 2023 was transformational for Unicycive
and positions us for continued success throughout the balance of
the year and beyond as we expect to file our New Drug Application
(NDA) for Renazorb™ in the third quarter of 2023 and, if approved,
plan for its potential commercial launch in 2024, which should
provide additional funding in connection with our recent financing
agreement,” said Shalabh Gupta, M.D., Chief Executive Officer of
Unicycive.
“Additionally, we continue to expand our scientific and clinical
body of evidence for both of our product candidates’ potential to
transform the treatment of acute and chronic kidney disease. The
Unicycive team has presented data from studies of Renazorb and
UNI-494 at key renal medical meetings worldwide. We will continue
to share data demonstrating the potential of our lead programs in
kidney disease before audiences of the world’s leading
nephrologists and believe it may enhance our commercial launch
efforts for Renazorb and our development efforts as we advance our
global clinical trials for UNI-494,” concluded Dr. Gupta.
Key Highlights of the First Quarter and Recent
Months
- In
February 2023, Unicycive entered into an exclusive license
agreement with Lotus Pharmaceutical (“Lotus”, Taiwan TWSE ticker:
1795), a leading global pharmaceutical company, for the development
and commercialization of Renazorb (lanthanum dioxycarbonate)
in the Republic of Korea.
- In
early March 2023, the Company signed a securities purchase
agreement with certain healthcare-focused institutional investors
that provides for up to $130 million in gross proceeds through a
private placement that included initial upfront funding of $30
million with additional capital available to the Company at
increasing share prices upon achievement of milestones with
mandated dividends to shareholders as the Company generates cash
profits.
-
Presented data from clinical studies on Renazorb and pre-clinical
studies on UNI-494 in multiple conferences globally.
- Unicycive first-in-human Phase 1
study of UNI-494 in healthy volunteers in the United Kingdom has
completed enrollment of its first cohort. Following the completion
of this Phase 1 study, the Company plans to file a corresponding
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA) in 2024 for a Phase 2 trial in AKI
patients.
- This summer, the Company is
presenting preclinical data highlighting the safety and suggestive
efficacy of UNI-494 in oral presentations at the 60th European
Renal Association Congress (ERA 2023) taking place in Milan, Italy
from June 15-18, 2023.
Financial Results for the First Quarter Ended March 31,
2023
Licensing revenues were $0.7 million for the quarter ended March
31, 2023 due to a licensing agreement executed in February
2023.
Research and development expenses for the quarter ended March
31, 2023 were $3.0 million, compared to $1.9 million for the same
period in 2022. This increase was primarily attributable to
development costs of $1.0 million for product formulation, clinical
study, and preclinical study services in the current period. Labor,
consulting, and other costs increased $0.1 million.
General and administrative expenses for the quarter ended March
31, 2023 were $1.8 million, compared to $1.6 million for the same
quarter of 2022. This increase was primarily attributable to an
increase of $0.4 million in consulting and professional services
costs. Non-cash stock compensation costs decreased $0.1 million.
Insurance expense for directors and officers decreased $0.2
million, and rent, travel, supplies and other costs increased $0.1
million.
Net loss for the three-month period ended March 31, 2023 was
$14.6 million, or $0.97 per share of common stock, compared to a
net loss of $3.5 million, or $0.24 per share of common stock, for
the same three-month period in 2022. This increase was attributable
to increased development costs as well as the $10.4 million change
in fair value of warrant liability.
As of March 31, 2023, cash and cash equivalents totaled $24.3
million compared with $0.5 million in cash and cash equivalents
held at December 31, 2022. Following the close of the fourth
quarter ended December 31, 2022, the Company completed a securities
purchase agreement with certain healthcare-focused institutional
investors that will provide up to $130.0 million in gross proceeds
through a private placement and that included initial upfront
funding of $30.0 million.
About Renazorb (lanthanum dioxycarbonate)
Renazorb is an investigational phosphate binding agent utilizing
proprietary nanoparticle technology being developed for the
treatment of hyperphosphatemia in patients with chronic kidney
disease (CKD) on dialysis. Renazorb has over forty issued and
granted patents globally. Its potential best-in-class profile may
have meaningful patient adherence benefits over currently available
treatment options as it requires a smaller and fewer number of
pills per dose and is swallowed instead of chewed. The timing of
Renazorb’s expected launch coincides favorably with the pending
expansion of Medicare patient access to phosphate binders in 2025
when these products are added to the end stage renal disease (ESRD)
PPS through the Center for Medicare and Medicaid’s Transitional
Drug Add-On Payment Adjustment (“TDAPA”) program. The global market
opportunity for treating hyperphosphatemia is projected to be in
excess of $2.5 billion in 2023, with the United States accounting
for more than $1 billion of that total. Despite the availability of
several FDA-cleared medications, 75 percent of U.S. dialysis
patients fail to achieve the target phosphorus levels recommended
by published medical guidelines
About UNI-494
UNI-494 is a novel patent-protected drug that selectively binds
to the SUR2B subunit of the mitochondrial KATP channel and
activates it to restore mitochondrial function and reduce oxidative
stress. The totality of the data presented so far this year,
underscore UNI-494’s potential to be safe, reno-protective, and to
have low risk of drug-drug interactions, all of which are important
findings for this product candidate as a promising therapeutic for
AKI, a condition for which there are currently no FDA approved
therapies.
About Unicycive Therapeutics
Unicycive is focused on two kidney diseases with large unmet
medical needs. We are developing Renazorb, an investigational
phosphate binding agent using proprietary nanoparticle technology
for the treatment of patients with hyperphosphatemia. We plan to
file a New Drug Application (NDA) for Renazorb with the U.S. Food
and Drug Administration (FDA) mid-year. We are also developing
UNI-494, a new chemical entity with a novel mechanism of action
that restores mitochondrial function in acute and chronic diseases.
Our initial target for UNI-494 is acute kidney injury (AKI), for
which there are currently no FDA-approved medicines. For more
information, please visit www.unicycive.com.
Forward-looking statements 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,
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, 2022, 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.
Investor Contact:
ir@unicycive.com(650) 900-5470
Anne Marie FieldsStern Investor Relations
annemarie.fields@sternir.com212-362-1200
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--Tables to Follow— |
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Unicycive Therapeutics, Inc. |
|
|
|
|
|
|
|
Balance Sheets |
(in thousands, except for share and per share
amounts) |
|
|
|
|
|
|
|
As of |
|
As of |
|
|
December 31, |
|
March 31, |
|
|
2022 |
|
|
2023 |
|
|
|
|
|
|
(Unaudited) |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
455 |
|
|
$ |
24,332 |
|
Prepaid expenses and other current assets |
|
|
2,189 |
|
|
|
1,852 |
|
Total current assets |
|
|
2,644 |
|
|
|
26,184 |
|
Right of use asset, net |
|
|
152 |
|
|
|
997 |
|
Property, plant and equipment, net |
|
|
22 |
|
|
|
21 |
|
Total assets |
|
$ |
2,818 |
|
|
$ |
27,202 |
|
|
|
|
|
|
|
|
Liabilities, mezzanine equity, and stockholders’
deficit |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
892 |
|
|
$ |
790 |
|
Accrued liabilities |
|
|
2,237 |
|
|
|
1,698 |
|
Warrant liability |
|
|
- |
|
|
|
13,206 |
|
Operating lease liability - current |
|
|
155 |
|
|
|
276 |
|
Total current liabilities |
|
|
3,284 |
|
|
|
15,970 |
|
Operating lease liability - long term |
|
|
- |
|
|
|
715 |
|
Total liabilities |
|
|
3,284 |
|
|
|
16,685 |
|
Commitments and contingencies |
|
|
|
|
|
|
Mezzanine equity: |
|
|
|
|
|
|
Series A-1 preferred stock, $0.001 par value per share–zero and
30,190 shares authorized at December 31, 2022 and March 31, 2023,
respectively; zero and 30,190 shares issued and outstanding,
liquidation preference of zero and $30.6 million at December 31,
2022, and March 31, 2023, respectively |
|
|
- |
|
|
|
25,599 |
|
Stockholders’ deficit: |
|
|
|
|
|
|
Preferred stock, $0.001 par value per share – 10,000,000 and
9,969,810 shares authorized at December 31, 2022 and March 31,
2023, respectively; no shares issued and outstanding at December
31, 2022, and March 31, 2023 |
|
$ |
- |
|
|
$ |
- |
|
Common stock, $0.001 par value per share – 200,000,000 shares
authorized at December 31, 2022 and March 31, 2023; 15,231,655
shares issued and outstanding at December 31, 2022, and 15,233,836
shares issued and outstanding at March 31, 2023 |
|
|
15 |
|
|
|
15 |
|
Additional paid-in capital |
|
|
33,516 |
|
|
|
33,475 |
|
Accumulated deficit |
|
|
(33,997 |
) |
|
|
(48,572 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders’ deficit |
|
|
(466 |
) |
|
|
(15,082 |
) |
Total liabilities, mezzanine equity, and stockholders’ deficit |
|
$ |
2,818 |
|
|
$ |
27,202 |
|
|
|
|
|
|
|
|
Unicycive Therapeutics, Inc. |
|
|
|
|
|
|
|
Statements of Operations |
(in thousands, except for share and per share
amounts) |
(Unaudited) |
|
|
|
Three Months Ended |
|
|
March 31, |
2022 |
|
|
2023 |
|
|
|
|
|
|
Licensing revenues: |
|
$ |
- |
|
|
$ |
675 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
1,933 |
|
|
|
3,030 |
|
General and administrative |
|
|
1,604 |
|
|
|
1,847 |
|
Total operating expenses |
|
|
3,537 |
|
|
|
4,877 |
|
Loss from operations |
|
|
(3,537 |
) |
|
|
(4,202 |
) |
Other income (expenses): |
|
|
|
|
|
|
Interest income |
|
|
- |
|
|
|
14 |
|
Interest expense |
|
|
- |
|
|
|
(12 |
) |
Change in fair value of warrant liability |
|
|
- |
|
|
|
(10,375 |
) |
Total other income (expenses) |
|
|
- |
|
|
|
(10,373 |
) |
Net loss |
|
$ |
(3,537 |
) |
|
$ |
(14,575 |
) |
Deemed dividend to Series A-1 preferred stockholders |
|
|
- |
|
|
|
(192 |
) |
Net loss attributable to common stockholders |
|
$ |
(3,537 |
) |
|
$ |
(14,767 |
) |
Net loss per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.24 |
) |
|
$ |
(0.97 |
) |
Weighted-average shares
outstanding used in computing net loss per share, basic and
diluted |
|
|
15,004,617 |
|
|
|
15,232,406 |
|
|
|
|
|
|
|
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Unicycive Therapeutics (NASDAQ:UNCY)
過去 株価チャート
から 4 2024 まで 5 2024
Unicycive Therapeutics (NASDAQ:UNCY)
過去 株価チャート
から 5 2023 まで 5 2024