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 third quarter
ended September 30, 2021.
“In our Phase 1 clinical study, UBX1325, a
senolytic small molecule working through an entirely new mechanism
of action, has shown a favorable safety profile and very promising
evidence of biological activity through six months,
demonstrating durability,” said Anirvan Ghosh, Ph.D., chief
executive officer of UNITY. “As announced yesterday, we share the
excitement of the patient and physician community about the
potential for UBX1325 as a possible disease-modifying treatment to
fill the large and unmet need for options beyond anti-VEGF
therapies. Our team continues to advance the UBX1325 program in a
Phase 2 proof of concept study currently enrolling patients with
diabetic macular edema (DME), and we are using the promising data
from patients with age-related macular degeneration (AMD) in the
Phase 1 study to inform design of a Phase 2 study in wet AMD to
start in the first half of 2022.”
UNITY yesterday released 24-week data from its
Phase 1 study of UBX1325 in DME, along with 24-week and 12-week
(AMD-only cohort) data in patients with AMD, and will present
information about the UBX1325 program at Eyecelerator@AAO 2021 in
New Orleans on November 11, 2021, an invitation-only event
featuring ophthalmic innovation put on in partnership between the
American Academy of Ophthalmology and ASCRS.
Upcoming Milestones
- UBX1325
Phase 2a proof of concept study in DME had a first patient dosed in
June 2021 and is actively recruiting patients, with information
about that trial available here. Twelve-week safety and efficacy
data are expected in the first half of 2022.
- UBX1325
Phase 2 proof of concept study in AMD is expected to initiate in
the first half of 2022, with twelve-week safety and efficacy data
expected in the second half of 2022.
- UBX2050
(Tie2 mAb) and UBX2089 (alpha-Klotho) expected to enter
IND-enabling studies in 2022.
Third Quarter Financial
Results
Cash, cash equivalents, and marketable
securities totaled $88.5 million as of September 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
September 30, 2021 was $14.8 million compared to $24.6 million for
the three months ended September 30, 2020. Cash used in operations
during the nine months ended September 30, 2021 was $40.0 million
compared to $61.6 million for the nine months ended September 30,
2020.
Research and development expenses decreased by
$9.7 million, to $9.1 million for the three months ended September
30, 2021 from $18.8 million for the three months ended September
30, 2020. The decrease was primarily due to decreases of $4.1
million in net direct research and development expenses mainly due
to termination of OA studies, delayed manufacturing and reduction
in pre-clinical safety studies, $3.4 million in personnel costs due
to reduction in force, $1.2 million in facilities-related costs,
$0.8 million in laboratory supplies and $0.2 million in consultant
expenses.
General and administrative expenses decreased by
$0.8 million, to $5.7 million for the three months ended September
30, 2021 from $6.5 million for the three months ended September 30,
2020. The decrease was primarily due to a decrease of $0.4 million
in personnel costs due to reduction in force, $0.3 million in
facilities-related costs and $0.1 million in professional fees.
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 September 30, 2021, filed with the Securities and
Exchange Commission on November 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 |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
9,081 |
|
|
$ |
18,830 |
|
|
$ |
28,815 |
|
|
$ |
54,218 |
|
General and administrative |
|
|
5,747 |
|
|
|
6,530 |
|
|
|
17,952 |
|
|
|
18,803 |
|
Change in fair value of contingent consideration |
|
|
— |
|
|
|
(718 |
) |
|
|
— |
|
|
|
(33 |
) |
Impairment of long-lived assets |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
2,159 |
|
Total operating expenses |
|
|
14,828 |
|
|
|
24,642 |
|
|
|
46,767 |
|
|
|
75,147 |
|
Loss from operations |
|
|
(14,828 |
) |
|
|
(24,642 |
) |
|
|
(46,767 |
) |
|
|
(75,147 |
) |
Interest income |
|
|
20 |
|
|
|
226 |
|
|
|
82 |
|
|
|
1,093 |
|
Interest expense |
|
|
(792 |
) |
|
|
(499 |
) |
|
|
(2,351 |
) |
|
|
(499 |
) |
Other income (expense),
net |
|
|
(850 |
) |
|
|
(2,637 |
) |
|
|
(996 |
) |
|
|
296 |
|
Net loss |
|
|
(16,450 |
) |
|
|
(27,552 |
) |
|
|
(50,032 |
) |
|
|
(74,257 |
) |
Other comprehensive gain
(loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on marketable
debt securities |
|
|
— |
|
|
|
(166 |
) |
|
|
— |
|
|
|
(24 |
) |
Comprehensive loss |
|
$ |
(16,450 |
) |
|
$ |
(27,718 |
) |
|
$ |
(50,032 |
) |
|
$ |
(74,281 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.30 |
) |
|
$ |
(0.52 |
) |
|
$ |
(0.91 |
) |
|
$ |
(1.49 |
) |
Weighted-average number of shares used in computing net loss
per share, basic and diluted |
|
|
55,436,444 |
|
|
|
52,482,200 |
|
|
|
54,826,481 |
|
|
|
49,926,396 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unity Biotechnology,
Inc.Condensed Balance Sheets(In
thousands)
|
|
September 30, |
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
|
|
(Unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
21,994 |
|
|
$ |
17,807 |
|
Short-term marketable securities |
|
|
58,973 |
|
|
|
79,892 |
|
Prepaid expenses and other current assets |
|
|
3,209 |
|
|
|
3,167 |
|
Restricted cash |
|
|
550 |
|
|
|
— |
|
Total current assets |
|
|
84,726 |
|
|
|
100,866 |
|
Property and equipment, net |
|
|
10,608 |
|
|
|
12,627 |
|
Operating lease right-of-use
assets |
|
|
21,856 |
|
|
|
23,509 |
|
Long-term marketable
securities |
|
|
7,500 |
|
|
|
17,871 |
|
Restricted cash |
|
|
896 |
|
|
|
1,446 |
|
Other long-term assets |
|
|
105 |
|
|
|
— |
|
Total assets |
|
$ |
125,691 |
|
|
$ |
156,319 |
|
Liabilities and Stockholders’
Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,773 |
|
|
$ |
2,558 |
|
Accrued compensation |
|
|
3,398 |
|
|
|
5,355 |
|
Accrued and other current liabilities |
|
|
6,861 |
|
|
|
6,550 |
|
Current portion of long-term debt |
|
|
945 |
|
|
|
— |
|
Total current liabilities |
|
|
12,977 |
|
|
|
14,463 |
|
Operating lease liability, net of
current portion |
|
|
30,812 |
|
|
|
34,468 |
|
Long-term debt, net |
|
|
24,142 |
|
|
|
24,508 |
|
Other long-term liabilities |
|
|
23 |
|
|
|
— |
|
Total liabilities |
|
|
67,954 |
|
|
|
73,439 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
|
447,057 |
|
|
|
422,379 |
|
Related party promissory notes for purchase of common
stock |
|
|
— |
|
|
|
(210 |
) |
Accumulated other comprehensive gain |
|
|
6 |
|
|
|
5 |
|
Accumulated deficit |
|
|
(389,331 |
) |
|
|
(339,299 |
) |
Total stockholders’ equity |
|
|
57,737 |
|
|
|
82,880 |
|
Total liabilities and
stockholders’ equity |
|
$ |
125,691 |
|
|
$ |
156,319 |
|
|
|
|
|
|
|
|
|
|
MediaCanale CommunicationsJason
Sparkjason.spark@canalecomm.com
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