Unicycive Announces First Quarter 2024 Financial Results and Provides Business Update
May 13 2024 - 3:16PM
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 three months ended March 31, 2024, and
provided a business update.
“This is an exciting time for Unicycive as we
progress towards the conclusion of our pivotal clinical trial for
our lead asset oxylanthanum carbonate (OLC),” said Shalabh Gupta,
M.D., Chief Executive Officer of Unicycive. “The trial is
evaluating the tolerability, safety, and pharmacokinetics of
clinically effective doses of OLC in patients with chronic kidney
disease (CKD) on dialysis and it remains on track with topline data
expected later this quarter. If approved, OLC may provide a
meaningful improvement in the quality of life for CKD patients on
dialysis with hyperphosphatemia by reducing the pill burden volume
by more than 4-fold compared to the most prescribed phosphate
binder1.”
Dr. Gupta, continued, “We are also developing
UNI-494 for the prevention of delayed graft function (DGF) after
kidney transplantation and other conditions related to acute kidney
injury. This is an important indication as DGF is one of the most
serious complications resulting from kidney transplantation.
UNI-494 is advancing through the multiple ascending dose (MAD)
portion of its Phase 1 study, and we expect to complete the trial
and report the full results in the second half of this year.”
“A priority for us in 2024 is expanding
awareness of our programs within the medical and scientific
communities. This month we will be presenting important data on
both OLC and UNI-494 at two of the most prominent, global
nephrology meetings hosted by the National Kidney Foundation and
the European Renal Association. We look forward to providing
updates on our programs at these events for all of our
stakeholders,” concluded Dr. Gupta.
Key Highlights
- Topline data expected in the second
quarter of 2024 from the pivotal clinical trial of OLC in chronic
kidney disease (CKD) patients on dialysis with
hyperphosphatemia.
- Multiple
presentations related to OLC and UNI-494 will be presented at the
National Kidney Foundation (NKF) Spring Clinical Meeting (May
14-18) and the 61st European Renal Association (ERA) Congress (May
23-26). Among these presentations, a poster titled “Renal
Dietitians Perceive Phosphate Binder and Low Phosphorus Diet
Non-Compliance as Top Reasons for Above Target Serum Phosphorus
Concentrations”, by lead author Kathleen M. Hill Gallant from the
University of Minnesota-Twin Cities was among the top-rated
submissions to the NKF Spring Clinical Meeting. The poster reports
on the findings from a survey of 100 renal dietitians on factors
contributing to patient non-compliance to phosphate binder therapy
and the most appealing features of Oxylanthanum Carbonate, if
approved.
- Completed
enrollment in the open-label, single-arm, multicenter,
multidose pivotal clinical trial with OLC, a next-generation
lanthanum-based phosphate binding agent utilizing proprietary
nanoparticle technology being developed to treat hyperphosphatemia
in patients with CKD on dialysis.
- Granted orphan
drug designation (ODD) by the FDA to UNI-494 for the prevention of
DGF in kidney transplant patients. ODD may provide certain tax
credits for qualified clinical trials, exemption of user fees, and
the potential for seven years of market exclusivity after
approval. UNI-494 is a cytoprotective agent that elicits an
ischemic preconditioning effect by activating KATP channels in
mitochondria to restore cellular function.
- Presented new
data demonstrating statistically significant results for UNI-494 in
a preclinical model of DGF at the 29th International
Conference on Advances in Critical Care Nephrology AKI and CRRT
2024. The data provides additional evidence that UNI-494 may be a
valuable asset for prevention of DGF and other conditions related
to acute kidney injury.
- Successfully
completed the single ascending dose (SAD) portion of the Company’s
ongoing Phase 1 clinical trial in UNI-494. UNI-494 was
well-tolerated up to 160 mg administered as a single dose and was
chosen as the go-forward dose based on promising safety,
tolerability, and pharmacokinetic data. In the multiple ascending
dose (MAD) portion of the study, 80 mg is now being administered
twice-a-day to trial participants.
- Completed a
private placement with new and existing healthcare institutional
investors that generated $50 million in gross proceeds to
Unicycive.
Financial Results for the Quarter Ended
March 31, 2024
Licensing Revenues: There were no licensing
revenues recorded for the quarter ended March 31, 2024. Licensing
revenues of approximately $0.7 million were recorded in the three
months ended March 31, 2023, due to an upfront payment for a
licensing agreement entered into with Lotus International PTE
Ltd.
Research and development (R&D) Expenses:
R&D expenses were $6.8 million for the three months ended March
31, 2024, compared to $3.0 million for the three months ended March
31, 2023. The increase in research and development expenses was
primarily due to one time costs related to the OLC clinical
trial.
General and Administrative (G&A) Expenses:
G&A expenses were $2.4 million for the three months ended March
31, 2024, compared to $1.8 million for the three months ended March
31, 2023. The increase in general and administrative expenses was
primarily due to an increase in non-cash stock compensation
costs.
Other Income (Expenses): Other income (expenses)
was $11.8 million for the three months ended March 31, 2024,
compared to $10.4 million for the three months ended March 31,
2023. The increase was due primarily to a $11.8 million change in
fair value of our warrant liability.
Net Loss: Net loss attributable to common
stockholders for the three months ended March 31, 2024 was $21.2
million, or $0.61 per share of common stock, compared to a net loss
of $14.8 million, or $0.97 per share of common stock, for the three
months ended March 31, 2023. This increase was attributable
primarily to increased drug development costs and the change in
fair value of our warrant liability.
Cash Position: As of March 31, 2024, cash and
cash equivalents totaled $48.9 million. The Company believes that
it has sufficient resources to fund planned operations into
2026.
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 clinical development for the treatment of conditions
related to acute kidney injury. For more information, please
visit Unicycive.com and follow us on LinkedIn and YouTube.
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, 2023, 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.
1Sprague, et al, “High Phosphate-Binding
Capacity of Oxylanthanum Carbonate with a Low Medication Volume:
Comparison with Commercially Available Phosphate Binders”, American
Journal of Nephrology, September 2023
Investor Contact:
ir@unicycive.com (650) 900-5470
SOURCE: Unicycive Therapeutics, Inc.
|
Unicycive Therapeutics, Inc. |
|
Balance Sheets |
(In thousands, except for share and per share
amounts) |
|
|
|
|
|
|
|
|
|
As of |
|
|
As of |
|
|
|
December 31, |
|
|
March 31, |
|
|
|
2023 |
|
|
2024 |
|
Assets |
|
|
|
|
(Unaudited) |
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,701 |
|
|
$ |
48,930 |
|
Prepaid expenses and other current assets |
|
|
3,698 |
|
|
|
2,746 |
|
Total current assets |
|
|
13,399 |
|
|
|
51,676 |
|
Right of use asset, net |
|
|
766 |
|
|
|
686 |
|
Property, plant and equipment, net |
|
|
26 |
|
|
|
23 |
|
Total assets |
|
$ |
14,191 |
|
|
$ |
52,385 |
|
|
|
|
|
|
|
|
|
|
Liabilities, mezzanine
equity, and stockholders’ deficit |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
839 |
|
|
$ |
1,240 |
|
Accrued liabilities |
|
|
3,234 |
|
|
|
3,550 |
|
Dividends payable |
|
|
- |
|
|
|
208 |
|
Warrant liability |
|
|
13,134 |
|
|
|
24,941 |
|
Operating lease liability - current |
|
|
327 |
|
|
|
343 |
|
Total current liabilities |
|
|
17,534 |
|
|
|
30,282 |
|
Operating lease liability – long term |
|
|
466 |
|
|
|
372 |
|
Total liabilities |
|
|
18,000 |
|
|
|
30,654 |
|
Commitments and contingencies
(Note 8) |
|
|
|
|
|
|
|
|
Mezzanine equity: |
|
|
|
|
|
|
|
|
Series B-1 preferred stock, $0.001 par value per share – zero
shares authorized at December 31, 2023, and 50,000 shares
authorized at March 31, 2024; zero shares outstanding at December
31, 2023, and 50,000 shares outstanding at March 31, 2024 |
|
|
- |
|
|
|
46,187 |
|
Stockholders’ deficit: |
|
|
|
|
|
|
|
|
Series A-2 preferred stock, $0.001 par value per share – 43,649
Series A-2 shares authorized at December 31, 2023 and 21,388.01
Series A-2 Prime shares authorized at March 31, 2024; 43,649 Series
A-2 shares outstanding at December 31, 2023 and 19,991.51 Series
A-2 Prime shares outstanding at March 31, 2024 |
|
|
- |
|
|
|
- |
|
Preferred stock: $0.001 par value per share—9,296,161 and 9,904,773
shares authorized at December 31, 2023 and March 31, 2024,
respectively; zero shares issued and outstanding at December 31,
2023 and March 31, 2024 |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value per share – 200,000,000 shares
authorized at December 31, 2023 and March 31, 2024; 34,756,049 and
37,606,630 shares issued and outstanding at December 31, 2023 and
March 31, 2024, respectively |
|
|
35 |
|
|
|
37 |
|
Additional paid-in capital |
|
|
60,697 |
|
|
|
61,011 |
|
Accumulated deficit |
|
|
(64,541 |
) |
|
|
(85,504 |
) |
Total stockholders’ deficit |
|
|
(3,809 |
) |
|
|
(24,456 |
) |
Total liabilities and stockholders’ deficit |
|
$ |
14,191 |
|
|
$ |
52,385 |
|
Unicycive Therapeutics, Inc. |
|
Statements of Operations |
(In thousands, except for share and per share
amounts) |
(Unaudited) |
|
|
|
Three Months
EndedMarch 31, |
|
|
|
2023 |
|
|
2024 |
|
|
|
|
|
|
|
|
Licensing revenues: |
|
$ |
675 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
3,030 |
|
|
|
6,813 |
|
General and administrative |
|
|
1,847 |
|
|
|
2,391 |
|
Total operating expenses |
|
|
4,877 |
|
|
|
9,204 |
|
Loss from operations |
|
|
(4,202 |
) |
|
|
(9,204 |
) |
Other income (expenses): |
|
|
|
|
|
|
|
|
Interest income |
|
|
14 |
|
|
|
69 |
|
Interest expense |
|
|
(12 |
) |
|
|
(20 |
) |
Change in fair value of warrant liability |
|
|
(10,375 |
) |
|
|
(11,808 |
) |
Total other income (expenses) |
|
|
(10,373 |
) |
|
|
(11,759 |
) |
Net loss |
|
|
(14,575 |
) |
|
|
(20,963 |
) |
Deemed dividend to Series A-1
preferred stockholders |
|
|
(192 |
) |
|
|
- |
|
Dividend to Series B preferred
stockholders |
|
|
- |
|
|
|
(208 |
) |
Net loss attributable to
common stockholders |
|
$ |
(14,767 |
) |
|
$ |
(21,171 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.97 |
) |
|
$ |
(0.61 |
) |
Weighted-average shares
outstanding used in computing net loss per share, basic and
diluted |
|
|
15,232,406 |
|
|
|
34,912,692 |
|
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