Unicycive Announces Third Quarter 2023 Financial Results and Provides Business Update
November 14 2023 - 4:15PM
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 third quarter ended September 30, 2023,
and provided a business update.
“Gaining alignment with the FDA on our clinical
development plan for oxylanthanum carbonate (OLC) was a major
achievement as we are one step closer to potentially bringing a
much-needed therapy to individuals living with chronic kidney
disease on dialysis,” said Shalabh Gupta, M.D., Chief Executive
Officer of Unicycive. “With clear visibility on the path forward to
file an NDA, we expect to initiate the pivotal clinical trial
before the end of this year. Topline data is expected in mid-2024,
and we plan to finalize the NDA package and submit to the FDA
shortly thereafter.”
“In addition, last quarter we were excited to
welcome Dr. Sara Kenkare-Mitra to our Board of Directors, adding a
seasoned executive with decades of drug development and corporate
leadership experience. We also remain very active within the the
medical community with a booth at Kidney Week and positive results
published on the phosphate binding capacity for OLC,” concluded Dr.
Gupta.
Key Highlights
- Alignment with
the FDA:
- Reached
agreement with the U.S. Food and Drug Administration (FDA) in a
Type C meeting on the overall data package requirements to file a
New Drug Application (NDA) including clinical data, preclinical
data, and CMC (chemistry, manufacturing, and controls). The Agency
agreed with the Company’s study design for a pivotal clinical trial
of 60 participants to be evaluated for 4 weeks on OLC once
participants are titrated to clinically effective doses. The study
is designed to evaluate pharmacokinetics, tolerability and the
event rate for discontinuation; therefore, there is no statistical
analysis required to demonstrate efficacy. No other clinical study
is required. Unicycive believes that results from this pivotal
trial will enhance the OLC data package from preclinical studies
and our previously disclosed bioequivalence study.
- Addition to
Board of Directors:
- Strengthened our
Board of Directors with the addition of Sara Kenkare-Mitra, PhD,
adding decades of drug development and corporate leadership
experience. Dr. Kenkare-Mitra brings Unicycive expertise spanning
research, preclinical and clinical development, translational
medicine, manufacturing, and regulatory. Importantly, she has
played a key role in the filing of more than 100 investigational
new drug (IND) and clinical trial applications and worked on 11
drug approvals in multiple diseases.
- Publication and
Awareness Campaigns:
- Launched an
unbranded educational campaign at the American Society of
Nephrology’s Kidney Week to address why “Less Is More” when it
comes to the high pill burden currently associated with
hyperphosphatemia.
- Featured on the
Nasdaq Amplify Issuer Spotlight interview series that explores how
industry leaders within the small-cap community are evolving and
navigating challenges in various industries.
- The American
Journal of Nephrology published positive results on the phosphate
binding capacity for OLC showing that OLC had the lowest daily
phosphate binder dose volume and the lowest volume required to bind
one gram of phosphate compared to five other commercially available
phosphate binders.
Financial Results for the Third Quarter
Ended September 30, 2023
Licensing Revenues: Licensing revenues were $0
compared to $1.0 million for the same period in 2022, due to an
upfront payment for a licensing agreement entered into with Lee’s
Pharmaceutical (HK) Limited in July 2022.
Research and Development (R&D) Expenses:
R&D expenses were $3.4 million, compared to $4.8 million for
the same period in 2022. A decrease in drug development costs of
approximately $1.9 million was due to completion of significant
preclinical development work in the prior period. The decrease in
development costs was partially offset by increases in labor costs
of $0.1 million and non-cash stock compensation costs of $0.3
million.
General and Administrative (G&A) Expenses:
G&A expenses were $2.6 million, compared to $1.7 million for
the same period in 2022. This increase was primarily due to an
increase of $0.4 million in consulting and professional services
costs. Stock compensation costs increased $0.3 million from the
prior period. Labor, travel, rent, and other costs increased $0.3
million, and insurance expenses for directors and officers
decreased $0.1 million.
Other Income (Expenses): Other income (expenses)
increased $1.6 million due primarily to the change in fair value of
our warrant liability.
Net Loss: Net loss attributable to common
stockholders was $4.4 million, or $0.13 per share of common stock,
compared to a net loss of $5.6 million, or $0.37 per share of
common stock, for the same three-month period in 2022. This
decrease was attributable primarily to a $1.4 million change in
fair value of our warrant liability.
Cash Position: As of September 30, 2023, cash and cash
equivalents totaled $14.3 million which is expected to last into
the second half of 2024 including completion of the pivotal
clinical trial and topline data for OLC.
About Oxylanthanum Carbonate
(OLC)
Oxylanthanum carbonate 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).
OLC 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 lower pill burden for patients in terms of number and
size of pills per dose that are swallowed instead of chewed. Based
on a survey conducted in 2022, Nephrologists stated that the
greatest unmet need in the treatment of hyperphosphatemia with
phosphate binders is a lower pill burden and better patient
compliance.1 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.
Unicycive is seeking FDA approval of OLC via the
505(b)(2) regulatory pathway. As part of the clinical development
program, two clinical studies were conducted in over 100 healthy
volunteers. The first study was a dose-ranging Phase I study to
determine safety and tolerability. The second study was a
randomized, open-label, two-way crossover bioequivalence study to
establish pharmacodynamic bioequivalence between OLC and Fosrenol.
Based on the topline results of the bioequivalence study,
pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was
established.
Fosrenol® is a registered trademark of Shire
International Licensing BV.1Reason Research, LLC 2022 survey.
Results here.
About Unicycive
Therapeutics
Unicycive 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 late preclinical development for the treatment of acute
kidney injury. For more information, please visit
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
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
SOURCE: Unicycive Therapeutics, Inc.
--Tables to Follow--
Unicycive Therapeutics, Inc. |
|
|
|
|
|
|
|
Balance Sheets |
(in thousands, except for share and per share
amounts) |
|
|
As of |
|
As of |
|
|
December 31, |
|
September 30, |
|
|
2022 |
|
2023 |
|
|
|
|
|
(Unaudited) |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash |
|
$ |
455 |
|
|
$ |
14,345 |
|
Prepaid expenses and other current assets |
|
|
2,189 |
|
|
|
4,224 |
|
Total current assets |
|
|
2,644 |
|
|
|
18,569 |
|
Right of use asset, net |
|
|
152 |
|
|
|
845 |
|
Property, plant and equipment, net |
|
|
22 |
|
|
|
28 |
|
Total assets |
|
$ |
2,818 |
|
|
$ |
19,442 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ (deficit) equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
892 |
|
|
$ |
1,084 |
|
Accrued liabilities |
|
|
2,237 |
|
|
|
2,530 |
|
Warrant liability |
|
|
- |
|
|
|
11,528 |
|
Operating lease liability - current |
|
|
155 |
|
|
|
314 |
|
Total current liabilities |
|
|
3,284 |
|
|
|
15,456 |
|
Operating lease liability - long term |
|
|
- |
|
|
|
552 |
|
Total liabilities |
|
|
3,284 |
|
|
|
16,008 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ (deficit)
equity: |
|
|
|
|
|
|
Series A-2 preferred stock, $0.001 par value per share – zero and
43,649 shares authorized at December 31, 2022 and September 30,
2023, respectively; zero and 43,649 shares outstanding at December
31, 2022 and September 30, 2023, respectively |
|
|
- |
|
|
|
44 |
|
Preferred stock, $0.001 par value per share – 10,000,000 and
9,926,161 shares authorized at December 31, 2022 and September 30,
2023, respectively; zero shares issued and outstanding at December
31, 2022, and September 30, 2023 |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value per share – 200,000,000 shares
authorized at December 31, 2022 and September 30, 2023; 15,231,655
shares issued and outstanding at December 31, 2022, and 34,754,401
shares issued and outstanding at September 30, 2023 |
|
|
15 |
|
|
|
35 |
|
Additional paid-in capital |
|
|
33,516 |
|
|
|
60,098 |
|
Accumulated deficit |
|
|
(33,997 |
) |
|
|
(56,743 |
) |
Total stockholders’ (deficit) equity |
|
|
(466 |
) |
|
|
3,390 |
|
Total liabilities and stockholders’ (deficit) equity |
|
$ |
2,818 |
|
|
$ |
19,442 |
|
|
|
|
|
|
|
|
|
|
Unicycive Therapeutics, Inc. |
|
|
|
|
|
|
|
Statements of Operations |
(in thousands, except for share and per share
amounts) |
(Unaudited) |
|
|
Three Months Ended |
|
Three Months Ended |
|
|
September 30, |
|
September 30, |
2022 |
|
2023 |
|
|
|
|
|
Licensing revenues: |
|
$ |
951 |
|
|
$ |
- |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
4,803 |
|
|
|
3,372 |
|
General and administrative |
|
|
1,702 |
|
|
|
2,566 |
|
Total operating expenses |
|
|
6,505 |
|
|
|
5,938 |
|
Loss from operations |
|
|
(5,554 |
) |
|
|
(5,938 |
) |
Other income (expenses): |
|
|
|
|
|
|
Interest income |
|
|
- |
|
|
|
227 |
|
Interest expense |
|
|
(3 |
) |
|
|
(18 |
) |
Change in fair value of warrant liability |
|
|
- |
|
|
|
1,396 |
|
Total other income (expenses) |
|
|
(3 |
) |
|
|
1,605 |
|
Net loss |
|
|
(5,557 |
) |
|
|
(4,333 |
) |
Deemed dividend to Series A-1
preferred stockholders |
|
|
- |
|
|
|
(72 |
) |
Net loss attributable to
common stockholders |
|
$ |
(5,557 |
) |
|
$ |
(4,405 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.37 |
) |
|
$ |
(0.13 |
) |
Weighted-average shares outstanding used in computing net loss per
share, basic and diluted |
|
|
15,061,995 |
|
|
|
32,633,074 |
|
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