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 second quarter
ended June 30, 2021.
“This quarter has been exciting and productive,
marked by the compelling data from the Phase 1 study of UBX1325. In
addition to the reassuring safety profile, we observed initial
signs of efficacy in both vision and corresponding ocular
structures in patients suffering from advanced DME and wet AMD for
whom anti-VEGF therapy was no longer considered beneficial – and
who in fact hadn’t received any anti-VEGF therapy for at least
three months. This initial data has generated strong enthusiasm and
support from the physician community, and we have both completed
the enrollment of additional wet AMD patients in our Phase 1 study
and are rapidly recruiting in our international Phase 2a study in
DME,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY.
“There’s a large unmet need for treatment options beyond anti-VEGF
therapy, and UBX1325 may fill that void as a senolytic option
working through an entirely novel and potentially disease-modifying
mechanism. We look forward to sharing additional data from the
Phase 1 study in the coming months, and the results of the Phase 2a
study in the first half of 2022.”
Key Business Highlights
Ophthalmology – UBX1325 Phase 1 Results
In July, UNITY announced positive data from its
Phase 1 safety study of UBX1325 in patients with advanced disease
from DME or wet AMD for whom anti-VEGF therapy was no longer
considered effective. In addition to a favorable safety and
tolerability profile, UBX1325, a small molecule inhibitor of
Bcl-xL, showed rapid improvements in these advanced patients.
Specifically, the majority of patients from this study showed a
positive gain in key clinical measures of disease progression,
including in best-corrected visual acuity (BCVA), central subfield
thickness (CST), and sub- and intra-retinal fluid (SRF, IRF).
The following improvements in vision and retinal structure were
observed as summarized below:
Treatment of patients with UBX1325 resulted in the
following clinical changes as of June 30, 2021:
Gain in ETDRS Letters from Baseline in Best-Corrected Visual
Acuity (BCVA)
- Overall (across all doses): 10 of
12 patients showed a gain in ETDRS letters from baseline in BCVA at
2 weeks; 9 of 12 patients showed a gain at 4 weeks
- In high dose groups (5, 10 mcg): 6
of 6 patients showed a gain in ETDRS letters from baseline in BCVA
at 2 weeks; 5 of 6 patients showed a gain at 4 weeks
Decrease in Central Subfield Thickness (CST)
- Overall (across all doses): 6 of 12
patients had a decrease (improvement) in CST at 2 weeks; 5 of 12
patients showed reductions at 4 weeks
- In high dose groups (5, 10 mcg): 4
of 6 patients showed decrease in CST at 2 weeks; 3 of 6 patients
showed reductions at 4 weeks
Reduction in Subretinal / Intraretinal Fluid
- 3 of 4 patients with wet AMD had a
reduction in subretinal / intraretinal fluid (SRF / IRF), and
improvement in disease-relevant pathology
Based on these data, the Company has, as of
August 5, 2021, completed the enrollment of additional patients
with advanced wet AMD in the Phase 1 study to inform a potential
Phase 2a study in wet AMD to start this fall. A parallel Phase 2a
proof-of-concept study in DME is actively recruiting patients, with
information about that trial available here.
Second Quarter Financial
Results
Cash, cash equivalents, and marketable
securities totaled $97.5 million as of June 30, 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 through the third quarter of 2022.
Operating loss for the three months ended June
30, 2021 was $17.0 million compared to $23.3 million for the three
months ended June 30, 2020. Cash used in operations during the
first and second quarters of 2021 was $28.5 million compared to
$44.4 million for the first and second quarters of 2020.
Research and development expenses decreased by
$5.1 million, to $11.0 million for the three months ended June 30,
2021 from $16.1 million for the three months ended June 30, 2020.
The decrease was primarily due to decreases of $3.2 million in
personnel costs due to reduction in force, $0.6 million in
laboratory supplies, $0.8 million in facilities-related costs, $0.1
million in consultant expenses, and $0.4 million in net direct
research and development expenses mainly due to termination of
UBX0101 offset by increase of $2.0 million in license expense from
Ascentage International reaching a milestone, which was a non-cash
expense.
General and administrative expenses decreased by
$0.3 million, to $6.0 million for the three months ended June 30,
2021 from $6.3 million for the three months ended June 30, 2020.
The decrease was primarily due to a decrease of $0.6 million in
personnel costs due to reduction in force, offset by increases of
$0.1 million in facilities-related costs, $0.1 million in
professional fees and $0.1 million in insurance-related
expense.
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. In its Phase 1 safety
trial in patients with advanced DME or wet AMD who were no longer
expected to benefit from anti-VEGF therapies, UBX1325 showed a
favorable safety and tolerability profile as well as initial
evidence of relevant biological efficacy. UNITY’s goal with UBX1325
is to transformationally improve real-world outcomes for patients
with DME, AMD, and DR.
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.
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 June 30, 2021, filed with the Securities and
Exchange Commission on August 10, 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) (Unaudited)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
11,016 |
|
|
$ |
16,123 |
|
|
$ |
19,733 |
|
|
$ |
35,388 |
|
General and administrative |
|
|
5,980 |
|
|
|
6,320 |
|
|
|
12,206 |
|
|
|
12,273 |
|
Change in fair value of contingent consideration |
|
|
— |
|
|
|
906 |
|
|
|
— |
|
|
|
685 |
|
Impairment of long-lived assets |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,159 |
|
Total operating expenses |
|
|
16,996 |
|
|
|
23,349 |
|
|
|
31,939 |
|
|
|
50,505 |
|
Loss from operations |
|
|
(16,996 |
) |
|
|
(23,349 |
) |
|
|
(31,939 |
) |
|
|
(50,505 |
) |
Interest income |
|
|
26 |
|
|
|
340 |
|
|
|
62 |
|
|
|
867 |
|
Interest expense |
|
|
(784 |
) |
|
|
— |
|
|
|
(1,559 |
) |
|
|
— |
|
Other income (expense),
net |
|
|
(72 |
) |
|
|
4,342 |
|
|
|
(146 |
) |
|
|
2,933 |
|
Net loss |
|
|
(17,826 |
) |
|
|
(18,667 |
) |
|
|
(33,582 |
) |
|
|
(46,705 |
) |
Other comprehensive gain
(loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on
marketable debt securities |
|
|
(10 |
) |
|
|
(141 |
) |
|
|
— |
|
|
|
142 |
|
Comprehensive loss |
|
$ |
(17,836 |
) |
|
$ |
(18,808 |
) |
|
$ |
(33,582 |
) |
|
$ |
(46,563 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.32 |
) |
|
$ |
(0.38 |
) |
|
$ |
(0.62 |
) |
|
$ |
(0.96 |
) |
Weighted-average number of shares used in computing net loss per
share, basic and diluted |
|
|
54,859,727 |
|
|
|
49,659,153 |
|
|
|
54,516,445 |
|
|
|
48,606,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unity Biotechnology,
Inc. Condensed Balance
Sheets (In thousands)
|
|
June 30, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,498 |
|
|
$ |
17,807 |
|
Short-term marketable securities |
|
|
70,445 |
|
|
|
79,892 |
|
Prepaid expenses and other current assets |
|
|
3,665 |
|
|
|
3,167 |
|
Total current assets |
|
|
87,608 |
|
|
|
100,866 |
|
Property and equipment, net |
|
|
11,251 |
|
|
|
12,627 |
|
Operating lease right-of-use
assets |
|
|
22,416 |
|
|
|
23,509 |
|
Long-term marketable
securities |
|
|
13,542 |
|
|
|
17,871 |
|
Restricted cash |
|
|
1,446 |
|
|
|
1,446 |
|
Total assets |
|
$ |
136,263 |
|
|
$ |
156,319 |
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,898 |
|
|
$ |
2,558 |
|
Accrued compensation |
|
|
2,613 |
|
|
|
5,355 |
|
Accrued and other current liabilities |
|
|
8,884 |
|
|
|
6,550 |
|
Total current liabilities |
|
|
13,395 |
|
|
|
14,463 |
|
Operating lease liability, net of
current portion |
|
|
32,036 |
|
|
|
34,468 |
|
Long-term debt, net |
|
|
24,892 |
|
|
|
24,508 |
|
Other long-term liabilities |
|
|
23 |
|
|
|
— |
|
Total liabilities |
|
|
70,346 |
|
|
|
73,439 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
438,788 |
|
|
|
422,379 |
|
Related party promissory notes for purchase of common stock |
|
|
— |
|
|
|
(210 |
) |
Accumulated other comprehensive gain |
|
|
5 |
|
|
|
5 |
|
Accumulated deficit |
|
|
(372,881 |
) |
|
|
(339,299 |
) |
Total stockholders’ equity |
|
|
65,917 |
|
|
|
82,880 |
|
Total liabilities and
stockholders’ equity |
|
$ |
136,263 |
|
|
$ |
156,319 |
|
|
|
|
|
|
|
|
|
|
Media
Canale Communications
Jason Spark
jason.spark@canalecomm.com
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