Unum Therapeutics Reports Third Quarter 2019 Financial Results
November 12 2019 - 4:30PM
Unum Therapeutics Inc. (NASDAQ: UMRX), a clinical-stage
biopharmaceutical company focused on developing curative cell
therapies for cancer, today reported financial results and
corporate updates for the third quarter ended September 30, 2019,
and provided recent activities.
“Our recently announced strategic focus towards
addressing the challenge of treating solid tumor cancers is well
underway with ACTR707, BOXR1030, and our BOXR platform that is
designed to discover new product candidates aimed at improving the
function of T cell therapies in the solid tumor microenvironment,”
said Chuck Wilson Ph.D., President and Chief Executive Officer of
Unum. “BOXR1030, which co-expresses the GOT2 transgene and is
designed to improve T cell metabolism and reduce T cell exhaustion,
generated complete tumor regressions under metabolically
challenging conditions in preclinical studies as presented at the
SITC meeting. For ACTR707, our Phase 1 trial is progressing
nicely and we remain on track to report enrollment and early safety
updates from patients treated in the first dose cohort by the end
of this year.”
Recent Program and Corporate
Highlights
- Announced strategic focus on developing best-in-class
cellular therapies for solid tumor cancers: Unum is
uniquely positioned to address the challenge of treating solid
tumor cancers with its two platforms—ACTR and BOXR—having recently
validated ACTR in the hematologic setting and with preclinical data
recently emerging from BOXR1030, the first product candidate from
BOXR. Unum’s ACTR platform enables selective T cell targeting for
on-tumor attack while its BOXR platform is designed to improve T
cell functionality in the solid tumor microenvironment (TME)
through the co-expression of novel transgenes. Unum’s priorities in
solid tumors include: 1) completing the ongoing ATTCK-34-01 Phase 1
trial of ACTR707 in HER2+ cancers, 2) advancing BOXR1030 towards
the clinic with an anticipated IND filing in late 2020; and 3)
expanding its BOXR platform to accelerate discovery of new product
candidates across a broad range of immune cell therapies, including
both autologous and allogeneic approaches. Five clinical trial
sites are activated and Unum expects to report preliminary safety
data from patients treated in the first dose cohort of the Phase 1
ATTCK-34-01 trial of ACTR707 combined with trastuzumab to treat
advanced HER2+ solid tumor cancers by the end of this year, and to
report safety and clinical response data from multiple dose cohorts
in 2020.
- Presented preclinical data for
BOXR1030 at the Society for Immunotherapy of Cancer (SITC) Annual
Meeting (November 6-10): BOXR1030 expresses a glypican-3
(GPC3) targeted chimeric antigen receptor (CAR) with the addition
of the “bolt-on” transgene glutamic-oxaloacetic transaminase 2
(GOT2) to improve T cell function in the TME by enhancing T cell
metabolism. As presented at the SITC conference, expression of the
GOT2 mitochondrial enzyme in BOXR1030 increased the production of
key amino acids and metabolites, improved the anti-oxidant balance
of T cells, and prevented their dysfunction and exhaustion in
preclinical studies using stringent animal xenograft models that
simulate the TME. In vitro, BOXR1030 T cells were resistant to
suppressive TME-like conditions, showing improved T cell
proliferation under both hypoxic and low glucose conditions
compared with control GPC3+ CAR-T cells. In vivo, BOXR1030
demonstrated superior activity compared to the control CAR-T with
treated animals achieving complete tumor regressions under
metabolically challenging conditions. Tumor infiltrating
lymphocytes isolated from the tumors of treated animals revealed
that BOXR1030 cells were more resistant to dysfunction, had fewer
markers of exhaustion, and remained functional as compared to the
control CAR-T cells.
- Announced de-prioritized investment in hematologic
programs. The clinical response and tolerability data
recently generated from the ATTCK-20-03 Phase 1 trial in
non-Hodgkin lymphoma established proof-of-concept for ACTR707,
allowing the company to focus its efforts towards the ATTCK-34-01
Phase 1 trial in solid tumors, a clinical setting for which ACTR707
was originally developed. With favorable tolerability at relatively
low doses explored to date, Unum announced plans to continue
limited dose escalation to inform potential future development of
the program in 2020.
Separately, Unum and its partner, Seattle
Genetics, Inc., have suspended further dose-escalation of the
ATTCK-17-01 Phase 1 trial of ACTR087 with SEA-BCMA in multiple
myeloma pending a further review of this program. Two additional
cohorts of patients have been treated in the Phase 1 trial in 2019,
escalating doses of the SEA-BCMA antibody to 2.0 mg/kg and of the
ACTR087+ T cells to 50M. No dose-limiting toxicities (DLTs)
following ACTR087 administration were reported and no severe
adverse events of cytokine release syndrome (CRS) or neurologic
events have been observed to date.
- Announced accepted oral and poster presentations at
upcoming American Society of Hematology (ASH) Annual Meeting,
December 7-10, Orlando, FL.
- Title: “A Phase 1 Study of ACTR087 in Combination with
Rituximab, in Subjects with Relapsed or Refractory CD20-Positive
B-Cell Lymphoma”Presenting Author: Javier Munoz, M.D., M.S., Banner
MD Anderson Cancer Center, Gilbert AZDate & Time: Oral #244,
Saturday, December 7, 2019, 2:45 p.m. ET
- Title: “Preliminary Clinical Results from a Phase 1 Study of
ACTR707 in Combination With Rituximab in Subjects with Relapsed or
Refractory CD20+ Non-Hodgkin Lymphoma”Presenting Author: Ian Flinn,
M.D., Ph.D., Sarah Cannon Research Institute, Nashville, TN Date
& Time: Poster #1587, Saturday, December 7, 2019, 5:30 p.m.
ET
Third Quarter 2019 Financial
Results
- Collaboration Revenue:
Collaboration revenue recognized during the third quarter ended
September 30, 2019 was $1.0 million, compared to $2.0 million in
the same period of 2018. Collaboration revenue, which includes the
recognition of a portion of the upfront payment received
from Seattle Genetics, Inc. as well as reimbursements of
research and development costs attributed to the Seattle Genetics,
Inc. collaboration agreement, decreased as a result of fewer
activities related to the programs under the collaboration
agreement.
- R&D Expenses: Research and
development expenses were $10.3 million for the third quarter
ended September 30, 2019 compared to $10.3 million for the
same period of 2018. Research and development expenses relate
to costs for the ongoing Phase 1 trials and preclinical programs,
as well as personnel-related costs to support these
programs.
- G&A
Expenses: General and administrative
expenses for the third quarter ended September 30, 2019 were $2.7
million, compared to $2.4 million for the same period of 2018.
The increase is primarily related to increased headcount and
personnel-related costs as well as expenses required to operate as
a public company.
- Net Loss: Net loss attributable to common
stockholders was $12.0 million, or $0.39 per
share, for the third quarter ended September 30, 2019 compared with
a net loss attributable to common stockholders of $10.2
million, or $0.34 per share, for the same period of
2018.
- Cash and Cash Equivalents: As of
September 30, 2019, Unum had cash and cash equivalents of $45.9
million. Unum believes that its existing cash and cash equivalents
will fund operating expenses and capital expenditure requirements
into early 2021.
About Unum TherapeuticsUnum
Therapeutics is a clinical-stage biopharmaceutical company focused
on developing curative cell therapies to treat a broad range of
cancer patients. Unum’s novel proprietary technologies include
Antibody-Coupled T cell Receptor (ACTR), an autologous engineered
T-cell therapy that combines the cell-killing ability of T cells
and the tumor-targeting ability of co-administered antibodies to
exert potent antitumor immune responses, and Bolt-On Chimeric
Receptor (BOXR), designed to improve the functionality of
engineered T cells by incorporating a “bolt-on” transgene to
overcome resistance of the solid tumor microenvironment to T cell
attack. Unum has multiple programs in Phase 1 clinical and
preclinical testing, including; ACTR707 used in combination with
trastuzumab in adult patients with HER2+ advanced cancer and used
in combination with rituximab in adult patients with r/r NHL; and
BOXR1030 expressing the GOT2 transgene and targeting GPC3+ solid
tumor cancers. The Company is headquartered in Cambridge, MA.
Follow Unum Therapeutics on social media:
@UnumRx, and LinkedIn.
Forward looking Statements
This press release contains forward-looking
statements including, without limitation, statements regarding our
future expectations, plans and prospects, including projections
regarding future revenues and financial performance, our long-term
growth, enrollment and results for our preclinical and clinical
activities, the development of our product candidates, including
the ACTR product candidates and the BOXR platform and product
candidates, and the anticipated timing and success of any of our
preclinical studies, clinical trials and regulatory filings, as
well as other statements containing the words "anticipate,"
"believe," "continue," "could," "estimate," "expect," "intend,"
"may," "might," "plan," "potential," "predict," "project,"
"should," "target," "will," or "would" and similar expressions,
constitute forward-looking statements within the meaning of the
safe harbor provisions of The Private Securities Litigation Reform
Act of 1995, as amended. We may not actually achieve the forecasts
disclosed in our forward-looking statements, and you should not
place undue reliance on our forward-looking statements. Actual
results could differ materially from the projections disclosed in
the forward-looking statements we make as a result of a variety of
risks and uncertainties, including risks related to the accuracy of
our estimates regarding expenses, future revenues, capital
requirements, and the need for additional financing, the success,
cost and timing of our product development activities and clinical
trials, our ability to obtain and maintain regulatory approval for
our product candidates, and the other risks and uncertainties
described in the "Risk Factors" sections of our public filings with
the Securities and Exchange Commission. In addition, the
forward-looking statements included in this press release represent
our views as of the date hereof. We anticipate that subsequent
events and developments may cause our views to change. However,
while we may elect to update these forward-looking statements at
some point in the future, we specifically disclaim any obligation
to do so. These forward-looking statements should not be relied
upon as representing our views as of any date subsequent to the
date hereof.
Investor Contact: Stern Investor Relations, Inc. Stephanie
Ascher, 212-362-1200 stephanie@sternir.com
Media Contact:Lissette Steele,
202-930-4762lsteele@vergescientific.com
UNUM THERAPEUTICS INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, $ in thousands, except share and per share
amounts)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Collaboration revenue |
|
$ |
1,020 |
|
|
$ |
2,043 |
|
|
$ |
7,211 |
|
|
$ |
5,929 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
10,335 |
|
|
|
10,252 |
|
|
|
33,355 |
|
|
|
27,520 |
|
General and administrative |
|
|
2,721 |
|
|
|
2,367 |
|
|
|
8,274 |
|
|
|
5,410 |
|
Total operating expenses |
|
|
13,056 |
|
|
|
12,619 |
|
|
|
41,629 |
|
|
|
32,930 |
|
Loss from operations |
|
|
(12,036 |
) |
|
|
(10,576 |
) |
|
|
(34,418 |
) |
|
|
(27,001 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
31 |
|
|
|
405 |
|
|
|
206 |
|
|
|
745 |
|
Other income, net |
|
|
82 |
|
|
|
3 |
|
|
|
82 |
|
|
|
330 |
|
Total other income, net |
|
|
113 |
|
|
|
408 |
|
|
|
288 |
|
|
|
1,075 |
|
Net loss |
|
|
(11,923 |
) |
|
|
(10,168 |
) |
|
|
(34,130 |
) |
|
|
(25,926 |
) |
Accretion of redeemable
convertible preferred stock to redemption value |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(16 |
) |
Net loss attributable to common
stockholders |
|
$ |
(11,923 |
) |
|
$ |
(10,168 |
) |
|
$ |
(34,130 |
) |
|
$ |
(25,942 |
) |
Net loss per share attributable
to common stockholders, basic and diluted |
|
$ |
(0.39 |
) |
|
$ |
(0.34 |
) |
|
$ |
(1.12 |
) |
|
$ |
(1.12 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
30,661,125 |
|
|
|
29,879,476 |
|
|
|
30,418,752 |
|
|
|
23,169,348 |
|
UNUM THERAPEUTICS INC. CONSOLIDATED
SELECTED BALANCE SHEET DATA (unaudited, in thousands)
|
|
September 30, 2019 |
|
|
December 31, 2018 |
|
Cash, cash equivalents and marketable securities |
|
$ |
45,882 |
|
|
$ |
78,594 |
|
Working capital |
|
$ |
23,548 |
|
|
$ |
56,057 |
|
Total assets |
|
$ |
57,884 |
|
|
$ |
85,927 |
|
Total liabilities |
|
$ |
29,261 |
|
|
$ |
25,693 |
|
Total stockholders’ equity |
|
$ |
28,623 |
|
|
$ |
60,234 |
|
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