UNITY Biotechnology, Inc. (UNITY) [NASDAQ:UBX], a biotechnology
company developing therapeutics to slow, halt, or reverse diseases
of aging, today reported financial results for the first quarter
ended March 31, 2021.
“The highlight of the quarter was the completion
of the initial assessment of patients in our Phase 1 safety study
of UBX1325, a senolytic molecule that has the potential to promote
reparative vascular remodeling in the retina in various age-related
eye diseases such as diabetic macular edema and age-related macular
degeneration and could provide a disease-modifying alternative to
current VEGF-targeting therapies,” said Anirvan Ghosh, Ph.D., chief
executive officer of UNITY. “We are excited by this safety and
tolerability data as well as initial evidence of relevant
biological activity, and are very pleased to have initiated a Phase
2a proof-of-concept study of UBX1325.”
Key Business Highlights
Ophthalmology – UBX1325
In October 2020, UNITY began its Phase 1 study
of UBX1325 in patients with diabetic macular edema (DME) and wet
age-related macular degeneration (AMD). The ongoing Phase 1 study
includes patients with a diagnosis of DME or AMD with significant
visual impairment and who are no longer candidates for
anti-vascular endothelial growth factor (VEGF) therapy. UBX1325,
the first senolytic agent to be administered to these patient
populations, has been well tolerated with no significant
treatment-associated adverse events in either disease
population.
The initial assessment of the Phase 1,
first-in-human, open-label, single-ascending dose study included 12
patients with advanced DME or wet AMD. The primary outcome measure
is ocular and systemic safety and tolerability of a single
intravitreal injection of UBX1325 evaluated by the
incidence of dose limiting toxicities (DLTs) and treatment emergent
adverse events (TEAEs) reported up to 24 weeks after
administration. The single intravitreal injection of UBX1325 was
well tolerated and had no adverse findings that would limit
advancement of UBX1325 into further clinical investigation. Based
on prospectively determined safety criteria, the Phase 1 study was
able to dose-escalate beyond the originally planned 5 mcg dose up
to 10 mcg, which will inform the final dose for the Phase 2a study
in DME which is expected to read out in 2022. In addition, based on
encouraging early data, UNITY intends to recruit additional
patients with wet AMD into the Phase 1 study to potentially support
an additional, independent Phase 2a study in wet AMD, which could
also read out in 2022. The company intends to share details of the
activity profile of UBX1325 from this Phase 1 study, including data
on best-corrected visual acuity (BCVA), central subfield thickness
(CST), and sub-retinal fluid (SRF), in the coming months.
Based on this initial data, UNITY has initiated
a Phase 2a proof-of-concept study to evaluate the safety, efficacy,
and durability of a single intravitreal injection of UBX1325 in a
broader population of patients with DME. Approximately 60 patients
will be enrolled in the study, randomized evenly between UBX1325
and sham-injected patients, and followed for 24 weeks
post-injection. Endpoints being explored in the study include
safety and tolerability, improvements in BCVA, CST, SRF, and
durability of effect. UNITY anticipates receiving initial results
from the Phase 2a proof-of-concept study in patients with DME in
the first of half of 2022.
“Mounting evidence shows an accumulation of
senescent cells in diseased retinal and choroidal tissue associated
with the vasculature – hallmarks of diabetic eye disease and other
age-related eye diseases,” said Jamie Dananberg, M.D., chief
medical officer of UNITY. “Senolytics represent a potential new
class of medicine designed to selectively target diseased blood
vessels to reduce vascular leakage, allow healthy vascular
remodeling, and restore retinal function. We find the data we have
seen to date very promising and look forward to evaluating both the
safety and efficacy of UBX1325 in advanced clinical studies.”
Operational Highlights
First Quarter Financial
Results
Cash, cash equivalents, and marketable
securities totaled $110.2 million as of March 31, 2021 compared
with $115.6 million as of December 31, 2020. UNITY believes that
current cash, cash equivalents, and marketable securities are
sufficient to fund operations into the second half of 2022.
Operating loss for the three months ended March
31, 2021 was $14.9 million compared to $27.2 million for the three
months ended March 31, 2020. Cash used in operations during the
first quarter of 2021 was $15.1 million compared to $25.1 million
for the first quarter of 2020.
Research and development expenses decreased by
$10.6 million, to $8.7 million for the three months ended March 31,
2021, from $19.3 million for the three months ended March 31, 2020.
The decrease was primarily due to decreases of $6.0 million in
direct research and development expenses due to termination of
osteoarthritis studies, $2.8 million in personnel costs due to
reduction in force, $0.9 million in laboratory supplies, and $0.9
million in facilities-related costs.
General and administrative expenses increased by
$0.3 million, to $6.2 million for the three months ended March 31,
2021, from $5.9 million for the three months ended March 31, 2020.
The increase was primarily due to increases of $0.4 million in
facilities-related costs and $0.1 million in insurance-related
expense, offset by a decrease of $0.2 million in professional
fees.
About UNITY
UNITY is developing a new class of therapeutics
to slow, halt, or reverse diseases of aging. UNITY’s current focus
is on creating medicines to selectively eliminate or modulate
senescent cells and thereby provide transformative benefit
in age-related ophthalmologic and neurologic diseases.
More information is available
at www.unitybiotechnology.com or follow us
on Twitter and LinkedIn.
About UBX1325
UBX1325 is an investigational compound being
studied for age-related diseases of the eye, including diabetic
macular edema (DME), age-related macular degeneration (AMD), and
diabetic retinopathy (DR). UBX1325 is a potent small molecule
inhibitor of Bcl-xL, a member of the Bcl-2 family of
apoptosis-regulatory proteins. UBX1325 is designed to inhibit the
function of proteins senescent cells rely on for survival. In
preclinical studies, UNITY has demonstrated that targeting Bcl-xL
with UBX1325 preferentially eliminates senescent cells from
diseased tissue while sparing healthy cells. UNITY’s goal with
UBX1325 is to transformationally improve real-world outcomes for
patients with DME, AMD, and DR.
Forward-Looking Statements
This press release contains forward-looking
statements including statements related to UNITY’s understanding of
cellular senescence and the role it plays in diseases of aging, the
potential for UNITY to develop therapeutics to slow, halt, or
reverse diseases of aging, including for ophthalmologic and
neurologic diseases, our expectations regarding potential benefits,
activity, effectiveness, and safety of UBX1325, the potential for
UNITY to successfully commence and complete clinical studies of
UBX1325 for DME, AMD, and other ophthalmologic diseases, the
expected timing of results of our studies of UBX1325, the timing of
the expected commencement, progression, and conclusion of our
studies including those of UBX1325, and UNITY’s expectations
regarding the sufficiency of its cash runway. These statements
involve substantial known and unknown risks, uncertainties, and
other factors that may cause our actual results, levels of
activity, performance, or achievements to be materially different
from the information expressed or implied by these forward-looking
statements, including the risk that
the COVID-19 worldwide pandemic may continue to
negatively impact the development of preclinical and clinical drug
candidates, including delaying or disrupting the enrollment of
patients in clinical trials, risks relating to the uncertainties
inherent in the drug development process, and risks relating to
UNITY’s understanding of senescence biology. We may not actually
achieve the plans, intentions, or expectations disclosed in our
forward-looking statements, and you should not place undue reliance
on our forward-looking statements. Actual results or events could
differ materially from the plans, intentions, and expectations
disclosed in the forward-looking statements we make. The
forward-looking statements in this press release represent our
views as of the date of this release. We anticipate that subsequent
events and developments will cause our views to change. However,
while we may elect to update these forward-looking statements at
some point in the future, we have no current intention of doing so
except to the extent required by applicable law. You should,
therefore, not rely on these forward-looking statements as
representing our views as of any date subsequent to the date of
this release. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the business of UNITY in general, see UNITY’s most
recent Quarterly Report on Form 10-Q for the quarter
ended March 31, 2021, filed with the Securities and
Exchange Commission on May 11, 2021, as well as other
documents that may be filed by UNITY from time to time with
the Securities and Exchange Commission.
Unity Biotechnology,
Inc.Statements of Operations and Comprehensive
Loss(In thousands, except share and per share
amounts)
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
8,717 |
|
|
$ |
19,265 |
|
General and administrative |
|
|
6,226 |
|
|
|
5,953 |
|
Change in fair value of contingent consideration |
|
|
— |
|
|
|
(221 |
) |
Impairment of long-lived assets |
|
|
— |
|
|
|
2,159 |
|
Total operating expenses |
|
|
14,943 |
|
|
|
27,156 |
|
Loss from operations |
|
|
(14,943 |
) |
|
|
(27,156 |
) |
Interest income |
|
|
36 |
|
|
|
527 |
|
Interest expense |
|
|
(775 |
) |
|
|
— |
|
Other expense |
|
|
(74 |
) |
|
|
(1,409 |
) |
Net loss |
|
|
(15,756 |
) |
|
|
(28,038 |
) |
Other comprehensive loss |
|
|
|
|
|
|
|
|
Unrealized gain on marketable
debt securities |
|
|
10 |
|
|
|
283 |
|
Comprehensive loss |
|
$ |
(15,746 |
) |
|
$ |
(27,755 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.29 |
) |
|
$ |
(0.59 |
) |
Weighted-average number of shares used in computing net loss per
share, basic and diluted |
|
|
54,169,349 |
|
|
|
47,544,401 |
|
Unity Biotechnology,
Inc.Condensed Balance Sheets(In
thousands)
|
|
March 31, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
26,842 |
|
|
$ |
17,807 |
|
Short-term marketable securities |
|
|
73,617 |
|
|
|
79,892 |
|
Prepaid expenses and other current assets |
|
|
1,582 |
|
|
|
3,167 |
|
Total current assets |
|
|
102,041 |
|
|
|
100,866 |
|
Property and equipment, net |
|
|
11,941 |
|
|
|
12,627 |
|
Operating lease right-of-use
assets |
|
|
22,967 |
|
|
|
23,509 |
|
Long-term marketable
securities |
|
|
9,790 |
|
|
|
17,871 |
|
Restricted cash |
|
|
1,446 |
|
|
|
1,446 |
|
Total assets |
|
$ |
148,185 |
|
|
$ |
156,319 |
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,975 |
|
|
$ |
2,558 |
|
Accrued compensation |
|
|
1,839 |
|
|
|
5,355 |
|
Accrued and other current liabilities |
|
|
6,455 |
|
|
|
6,550 |
|
Total current liabilities |
|
|
10,269 |
|
|
|
14,463 |
|
Operating lease liability, net of
current portion |
|
|
33,264 |
|
|
|
34,468 |
|
Long-term debt, net |
|
|
24,699 |
|
|
|
24,508 |
|
Total liabilities |
|
|
68,232 |
|
|
|
73,439 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
435,198 |
|
|
|
422,379 |
|
Related party promissory notes for purchase of common stock |
|
|
— |
|
|
|
(210 |
) |
Promissory notes for purchase of common stock |
|
|
(210 |
) |
|
|
— |
|
Accumulated other comprehensive gain |
|
|
15 |
|
|
|
5 |
|
Accumulated deficit |
|
|
(355,055 |
) |
|
|
(339,299 |
) |
Total stockholders’ equity |
|
|
79,953 |
|
|
|
82,880 |
|
Total liabilities and
stockholders’ equity |
|
$ |
148,185 |
|
|
$ |
156,319 |
|
Media
Canale Communications
Jason Spark
jason.spark@canalecomm.com
UNITY Biotechnology (NASDAQ:UBX)
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