Unicycive Announces Second Quarter 2024 Financial Results and Provides Business Update
August 14 2024 - 7:10AM
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 June 30, 2024, and
provided a business update.
“Achieving successful results from our
oxylanthanum carbonate (OLC) pivotal trial was a significant
milestone for the company and brings us one step closer to becoming
a commercial organization,” said Shalabh Gupta, M.D., Chief
Executive Officer of Unicycive. “Importantly, the trial confirmed
tolerability of OLC in patients with hyperphosphatemia on dialysis
which is the final data component needed to support submission of a
New Drug Application (NDA) to the FDA utilizing the 505(b)(2)
regulatory pathway. In addition, we were able to achieve phosphate
control in 90% of patients at the end of their titration. Our
recent pharmacokinetic analysis of samples from the pivotal study
revealed that the systemic exposure of our drug is minimal and, as
expected, the serum lanthanum levels are similar to that seen with
Fosrenol®. With this data, we believe that we have completed all
the necessary requirements from this pivotal clinical trial to
fulfill the FDA’s requests. We remain on track to submit our NDA by
the end of this month, and we maintain a high degree of confidence
in the potential for OLC to be a best-in-class commercial product,
if approved.”
“In July 2024 we were granted a new patent for
UNI-494 by the USPTO which is an important component of our
development strategy to target patients with acute kidney injury
(AKI), a serious condition resulting from a sudden loss of kidney
function. We have completed enrollment in the UNI-494 Phase 1
dose-ranging study and expect to report results in the third
quarter of this year. With assets targeting both chronic and acute
kidney conditions, we remain steadfastly focused on improving
treatment options and overall quality of life for patients living
with renal diseases,” concluded Dr. Gupta.
Key Highlights
- Reported
positive topline data from the pivotal clinical trial of OLC with
regard to both safety and tolerability endpoints. The study
established promising tolerability of OLC at clinically effective
doses in chronic kidney disease (CKD) patients on hemodialysis. In
terms of tolerability, OLC had a low rate of discontinuation due to
adverse events (AEs) with only 5/86 patients (6%) discontinuing
from the Study. The primary endpoint was defined as the rate of
discontinuations due to treatment-related AEs leading to
discontinuation in the maintenance period. In the UNI-OLC-201
trial, the discontinuation rate was 1.4%, as there was only 1
discontinuation due to a treatment-related AE in the Evaluable
Population (n=71). In the full Safety Population (n=86), a total of
3 patients discontinued due to treatment-related AEs, a rate of
3.5%. There were no treatment-related serious adverse events
(SAEs).
- Announced
initial results from the patient reported outcome survey conducted
during the UNI-OLC-201 pivotal clinical trial. In the survey, OLC
consistently outperformed the other phosphate binders in all
categories: 79% of patients preferred OLC while 18% preferred their
prior therapy, 98% of patients said that OLC was easy to take
compared to 55% for their prior therapy, 89% of patients said they
were satisfied with OLC while 49% were satisfied with their prior
therapy.
- Enrollment in
the UNI-494 Phase 1 study is complete, and the Company expects to
present the data in Q3 2024.
- Granted a
patent on UNI-494 to treat AKI by the United States Patent and
Trademark Office (USPTO). The patent, valid until 2040, secures
protection of a method of treating a disease or a condition
selected from AKI or contrast induced nephropathy by administering
the UNI-494 compound.
- Included in the
Russell Microcap® Index effective July 1, 2024. Membership in
the Russell Microcap® Index, which remains in place for one year,
means automatic inclusion in the appropriate growth and value style
indexes.
- Delivered
multiple presentations on OLC and UNI-494 at the 61st European
Renal Association (ERA) Congress including two oral presentations
and trial-in-progress posters on OLC and UNI-494. An oral
presentation demonstrated a significant reduction in urinary
phosphate excretion for OLC compared to vehicle treated animals. A
second oral presentation evaluated the in vivo efficacy of UNI-494
and showed that a single oral dose of UNI-494 significantly reduced
important kidney functional markers.
- Presented two
posters related to OLC at the National Kidney Foundation (NKF)
Spring Clinical Meeting. Importantly, it was demonstrated that OLC
is bioequivalent to lanthanum carbonate from the Phase 1,
single-center, randomized 1:1, open-label, controlled, 2-way
crossover study. In addition, a poster presentation on the findings
of a survey of 100 renal dieticians concluded that strategies that
reduce pill burden and increase ease of use for patients are
needed. This poster was among the top-rated submissions to the
Meeting.
Financial Results for the Quarter Ended
June 30, 2024
Research and Development (R&D) expenses were
$4.9 million for the three months ended June 30, 2024, compared to
$2.3 million for the three months ended June 30, 2023. The increase
in research and development expenses was primarily due to increased
drug development costs.
General and Administrative (G&A) expenses
were $2.5 million for the three months ended June 30, 2024,
compared to $2.1 million for the three months ended June 30, 2023.
The increase was primarily due to increased non-cash stock
compensation costs.
Other Income (Expense) was $17.3 million for the
three months ended June 30, 2024 compared to $0.5 million in the
three months ended June 30, 2023, due primarily to a decrease in
the fair value of our warrant liability.
Net income attributable to common stockholders
for the three months ended June 30, 2024 was $3.0 million, and
basic earnings per share was $0.08. On a diluted basis, we reported
a loss per share for the same period of $0.15. The net income for
the three-month period ended June 30, 2024 was attributable to a
decrease in the fair value of our warrant liability. For the three
months ended June 30, 2023, we reported a net loss of $4.4 million,
and basic loss per share of $0.29. On a diluted basis, we reported
a loss per share for the same period of $0.29.
As of June 30, 2024, cash and cash equivalents
totaled $41.8 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.
Fosrenol® is a registered trademark of Shire
International Licensing BV.
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, |
|
|
June 30, |
|
|
|
2023 |
|
|
2024 |
|
Assets |
|
|
|
|
(Unaudited) |
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,701 |
|
|
|
$ |
41,780 |
|
|
Prepaid expenses and other current assets |
|
|
3,698 |
|
|
|
|
2,274 |
|
|
Total current assets |
|
|
13,399 |
|
|
|
|
44,054 |
|
|
Right of use asset, net |
|
|
766 |
|
|
|
|
604 |
|
|
Property, plant and equipment, net |
|
|
26 |
|
|
|
|
43 |
|
|
Total assets |
|
$ |
14,191 |
|
|
|
$ |
44,701 |
|
|
|
|
|
|
|
|
|
|
|
Liabilities, mezzanine
equity, and stockholders’ deficit |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
839 |
|
|
|
$ |
1,472 |
|
|
Accrued liabilities |
|
|
3,234 |
|
|
|
|
3,122 |
|
|
Dividends payable |
|
|
- |
|
|
|
|
1 |
|
|
Warrant liability |
|
|
13,134 |
|
|
|
|
8,131 |
|
|
Operating lease liability - current |
|
|
327 |
|
|
|
|
360 |
|
|
Total current liabilities |
|
|
17,534 |
|
|
|
|
13,086 |
|
|
Operating lease liability – long term |
|
|
466 |
|
|
|
|
274 |
|
|
Total liabilities |
|
|
18,000 |
|
|
|
|
13,360 |
|
|
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 June 30, 2024; zero shares outstanding at December
31, 2023, and 50,000 shares outstanding at June 30, 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 June 30, 2024; 43,649 Series
A-2 shares outstanding at December 31, 2023 and 17,073.07 Series
A-2 Prime shares outstanding at June 30, 2024 |
|
|
- |
|
|
|
|
- |
|
|
Preferred stock: $0.001 par value per share—9,926,161 and 9,904,773
shares authorized at December 31, 2023 and June 30, 2024,
respectively; zero shares issued and outstanding at December 31,
2023 and June 30, 2024 |
|
|
- |
|
|
|
|
- |
|
|
Common stock, $0.001 par value per share – 200,000,000 shares
authorized at December 31, 2023 and 400,000,000 shares authorized
at June 30, 2024; 34,756,049 and 43,573,212 shares issued and
outstanding at December 31, 2023 and June 30, 2024,
respectively |
|
|
35 |
|
|
|
|
43 |
|
|
Additional paid-in capital |
|
|
60,697 |
|
|
|
|
60,760 |
|
|
Accumulated deficit |
|
|
(64,541 |
) |
|
|
|
(75,649 |
) |
|
Total stockholders’ deficit |
|
|
(3,809 |
) |
|
|
|
(14,846 |
) |
|
Total liabilities and stockholders’ deficit |
|
$ |
14,191 |
|
|
|
$ |
44,701 |
|
|
|
Unicycive Therapeutics, Inc.Statements of
Operations(In thousands, except for share and per
share amounts)(Unaudited) |
|
|
|
Three Months Ended June 30, |
|
|
|
2023 |
|
|
2024 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
2,267 |
|
|
|
$ |
4,868 |
|
|
General and administrative |
|
|
2,055 |
|
|
|
|
2,533 |
|
|
Total operating expenses |
|
|
4,322 |
|
|
|
|
7,401 |
|
|
Loss from operations |
|
|
(4,322 |
) |
|
|
|
(7,401 |
) |
|
Other income (expenses): |
|
|
|
|
|
|
|
|
Interest income |
|
|
234 |
|
|
|
|
462 |
|
|
Interest expense |
|
|
(32 |
) |
|
|
|
(16 |
) |
|
Change in fair value of warrant liability |
|
|
282 |
|
|
|
|
16,810 |
|
|
Total other income (expenses) |
|
|
484 |
|
|
|
|
17,256 |
|
|
Net income (loss) |
|
|
(3,838 |
) |
|
|
|
9,855 |
|
|
Deemed dividend to Series A-1
preferred stockholders |
|
|
(603 |
) |
|
|
|
- |
|
|
Dividend to Series B-1
preferred stockholders |
|
|
- |
|
|
|
|
(887 |
) |
|
Net income attributable to
participating securities |
|
|
- |
|
|
|
|
(5,925 |
) |
|
Net income (loss) attributable
to common stockholders |
|
$ |
(4,441 |
) |
|
|
$ |
3,043 |
|
|
Net income (loss) per share
attributable to common stockholders, basic |
|
$ |
(0.29 |
) |
|
|
$ |
0.08 |
|
|
Net loss per share
attributable to common stockholders, diluted |
|
$ |
(0.29 |
) |
|
|
$ |
(0.15 |
) |
|
Weighted-average shares
outstanding used in computing net income (loss) per share,
basic |
|
|
15,234,570 |
|
|
|
|
37,914,812 |
|
|
Weighted-average shares
outstanding used in computing net loss per share, diluted |
|
|
15,234,570 |
|
|
|
|
94,052,853 |
|
|
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