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 second quarter ended June 30, 2023, and
provided a business update.
“Data publications and presentations continue to
highlight the benefits of both our lead asset, Oxylanthanum
Carbonate (OLC), and UNI-494 targeting treatment for patients with
life threatening kidney diseases,” said Shalabh Gupta, M.D., Chief
Executive Officer of Unicycive. “For OLC, we expect to gain
alignment with the U.S. Food and Drug Administration in the Fall of
this year around the additional data requirements to advance the
program towards submission of a New Drug Application. As we
reported last month, recently published data demonstrated that OLC
has the potential to improve medication adherence and the quality
of life for patients suffering from chronic kidney disease. This
reinforces our commitment to bring this important new treatment
option to patients as soon as possible.”
“Preclinical data from UNI-494 presented this
quarter highlighted its novel mechanism of action to restore
mitochondrial function. Importantly, the data showed UNI-494 was
well tolerated and may protect the kidney against harmful effects
related to acute kidney injury, a condition for which there are
currently no approved treatments. Our Phase 1 study is ongoing in
the United Kingdom, and as we reported previously, we are
continuing with the healthy volunteer dosing. Concurrently, we plan
to request a pre-IND meeting with the FDA before the end of this
year to prepare to conduct further clinical studies in the U.S. in
2024,” concluded Dr. Gupta.
Key Highlights
- 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.
- Presented
preclinical data highlighting the potential safety and suggestive
efficacy of UNI-494 in oral presentations at the 60th European
Renal Association Congress (ERA 2023).
- Adopted the
non-proprietary name, oxylanthanum carbonate (OLC) by the United
States Adopted Name (USAN) organization, replacing
lanthanum dioxycarbonate (LDC).
Financial Results for the Second Quarter
Ended June 30, 2023
Research and Development (R&D) Expenses:
R&D expenses for the quarter ended June 30, 2023 were $2.3
million, compared to $1.9 million for the same period in 2022. This
increase was primarily attributable to an increase in development
costs of $0.3 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 (G&A) Expenses:
G&A for the quarter ended June 30, 2023 were $2.1 million,
compared to $1.8 million for the same quarter of 2022. This
increase was primarily attributable to an increase of $0.5 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 labor, rent,
travel, supplies and other costs increased $0.1 million.
Other Income (Expenses): Other income (expenses)
for the quarter ended June 30, 2023 increased $0.5 million due
primarily to the revaluation of the warrant liability.
Net Loss: Net loss attributable to common
stockholders for the quarter ended June 30, 2023 was $4.4 million,
or $0.29 per share of common stock, compared to a net loss of $3.6
million, or $0.24 per share of common stock, for the same
three-month period in 2022. This decrease was attributable
primarily to a $0.3 million increase in drug development costs.
Cash Position: As of June 30, 2023, cash and
cash equivalents totaled $18.8 million.
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 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 acute kidney injury, a
condition for which there are currently no FDA approved
therapies.
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.
Unicycive Therapeutics, Inc. |
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Balance Sheets |
(in thousands, except for share and per share
amounts) |
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As of |
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As of |
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December 31, |
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June 30, |
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2022 |
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2023 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash |
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$ |
455 |
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$ |
18,818 |
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Prepaid expenses and other current assets |
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2,189 |
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3,112 |
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Total current assets |
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2,644 |
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21,930 |
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Right of use asset, net |
|
|
152 |
|
|
|
923 |
|
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Property, plant and equipment, net |
|
|
22 |
|
|
|
30 |
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Total assets |
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$ |
2,818 |
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$ |
22,883 |
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Liabilities and
stockholders’ (deficit) equity |
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Current liabilities: |
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Accounts payable |
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$ |
892 |
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$ |
503 |
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Accrued liabilities |
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2,237 |
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1,689 |
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Warrant liability |
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- |
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12,924 |
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Operating lease liability - current |
|
|
155 |
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|
|
303 |
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Total current liabilities |
|
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3,284 |
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|
15,419 |
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Operating lease liability - long term |
|
|
- |
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|
|
634 |
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Total liabilities |
|
|
3,284 |
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|
|
16,053 |
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Commitments and
contingencies |
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Mezzanine equity: |
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Series A-1 preferred stock, $0.001 par value per share–zero and
30,190 shares authorized at December 31, 2022 and June 30, 2023,
respectively; zero and 30,190 shares issued and outstanding,
liquidation preference of zero and $31.0 million at December 31,
2022, and June 30, 2023, respectively |
|
|
- |
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26,202 |
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Stockholders’ deficit: |
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Preferred stock, $0.001 par value per share – 10,000,000 and
9,969,810 shares authorized at December 31, 2022 and June 30, 2023,
respectively; no shares issued and outstanding at December 31,
2022, and June 30, 2023 |
|
$ |
- |
|
|
$ |
- |
|
|
Common stock, $0.001 par value per share – 200,000,000 shares
authorized at December 31, 2022 and March 31, 2023; 15,231,655
shares issued and outstanding at December 31, 2022, and 15,236,016
shares issued and outstanding at June 30, 2023 |
|
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15 |
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15 |
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Additional paid-in capital |
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33,516 |
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33,023 |
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Accumulated deficit |
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(33,997 |
) |
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(52,410 |
) |
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Total stockholders’ deficit |
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(466 |
) |
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(19,372 |
) |
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Total liabilities, mezzanine equity, and stockholders’ deficit |
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$ |
2,818 |
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$ |
22,883 |
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Unicycive Therapeutics, Inc. |
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Statements of Operations |
(in thousands, except for share and per share
amounts) |
(Unaudited) |
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Three Months Ended |
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Three Months Ended |
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June 30, |
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June 30, |
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2022 |
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2023 |
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Licensing revenues: |
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$ |
- |
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$ |
- |
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Operating expenses: |
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|
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|
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Research and development |
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1,860 |
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|
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2,267 |
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General and administrative |
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1,776 |
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|
2,055 |
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Total operating expenses |
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3,636 |
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4,322 |
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Loss from operations |
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|
(3,636 |
) |
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(4,322 |
) |
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Other income (expenses): |
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Interest income |
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- |
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|
|
234 |
|
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Interest expense |
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- |
|
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(32 |
) |
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Change in fair value of warrant liability |
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- |
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282 |
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Total other income (expenses) |
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- |
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484 |
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Net loss |
|
$ |
(3,636 |
) |
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$ |
(3,838 |
) |
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Deemed dividend to Series A-1
preferred stockholders |
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- |
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|
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(603 |
) |
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Net loss attributable to
common stockholders |
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$ |
(3,636 |
) |
|
$ |
(4,441 |
) |
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Net loss per share
attributable to common stockholders, basic and diluted |
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$ |
(0.24 |
) |
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$ |
(0.29 |
) |
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Weighted-average shares outstanding used in computing net loss per
share, basic and diluted |
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15,028,689 |
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15,234,570 |
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Unicycive Therapeutics (NASDAQ:UNCY)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Unicycive Therapeutics (NASDAQ:UNCY)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024