Unum Therapeutics Reports First Quarter 2018 Financial Results and Provides Business Update
May 14 2018 - 7:00AM
– Successfully Completed IPO and Concurrent
Private Placement Raising $77 Million in Gross Proceeds –
Unum Therapeutics Inc. (NASDAQ:UMRX), a clinical-stage
biopharmaceutical company focused on the development of cellular
immunotherapies based on its novel, universal Antibody-Coupled
T-cell Receptor (ACTR) technology platform, today reported
financial results and provided a corporate update for the first
quarter ended March 31, 2018 and recent activities.
“Following our successful initial public offering in April 2018
and concurrent private placement, we are in a strong financial
position to continue developing our proprietary, universal ACTR
technology platform and rapidly advancing our pipeline of cellular
immunotherapies through clinical development,” said Chuck Wilson,
CEO of Unum. “We are currently evaluating the potential
of ACTR in combination with different tumor-targeting
antibodies, in three ongoing multi-center Phase I
trials, ATTCK-20-2 and ATTCK-20-03 evaluating ACTR087 and
ACTR707, respectively, in combination with rituximab in
patients with CD20+ r/r Non-Hodgkin
Lymphoma (NHL), and ATTCK-17-01
evaluating ACTR087 in combination with SEA-BCMA in
patients with r/r multiple myeloma. We expect to report
preliminary data from these three trials late this year. In
the second half of 2018 we also look forward to filing an IND and
initiating clinical development of ACTR707 in combination with
trastuzumab for the treatment of patients with HER2+ advanced
cancers, our first solid tumor product candidate.”
Recent Business Highlights and Outlook
- Successfully Completed IPO and Concurrent Private
Placement: In April, 2018, Unum successfully completed an
initial public offering (IPO) of 5,985,000 shares of common stock
at a public offering price of $12.00 per share, including the
exercise by the underwriters of 215,000 shares of their
overallotment option, raising $66.8 million in net proceeds. In
addition, with a private placement concurrent with the IPO, Seattle
Genetics, Inc. purchased $5.0 million shares of common stock at the
initial public offering price. The proceeds from the IPO and the
concurrent private placement will be used primarily to advance
Unum’s four lead ACTR development candidates.
- Initiated Cohort Expansion Phase of ATTCK-20-2 Phase I
trial; Plans to Expand Clinical Development: In May 2018,
Unum initiated the cohort expansion phase of the ATTCK-20-2 trial
evaluating safety and anti-lymphoma activity of ACTR087 at the
preliminary recommended phase 2 dose (RP2D) level used in
combination with rituximab in patients with CD20+ r/r NHL. Unum
expects to report updated data, including preliminary data from
this phase of the ATTCK-20-2 trial, in the fourth quarter of 2018.
- These data will also inform the strategy for a planned
multi-center Phase II clinical trial exploring ACTR T cells used in
combination with rituximab in patients with CD20+ r/r NHL who
received prior CD19 CAR T cell therapy.
- In addition, Unum intends to file a protocol amendment to the
ATTCK-20-2 trial in the second half of 2018 to explore ACTR087 in
combination with an alternative rituximab dosing regimen from that
currently being studied. Preclinical experiments have shown
that the level of ACTR T cell activity depends upon the amount of
the co-administered antibody. As such, ACTR087 safety and
anti-tumor activity in combination with rituximab in CD20+ r/r NHL
may be even further optimized by an alternative rituximab regimen.
Testing the alternative regimen will complement the clinical data
being generated to support additional clinical trials with the
combination.
- Initiated Patient Enrollment and Dosing in ATTCK-17-01
Phase I trial: In the first quarter, Unum initiated
patient enrollment in ATTCK-17-01, a Phase I, multi-center,
open-label clinical trial designed to test the safety,
tolerability, and anti-myeloma activity of ACTR087 used in
combination with SEA-BCMA in patients with r/r multiple
myeloma. Unum is currently enrolling and dosing patients in
this trial and expects to report preliminary data in the fourth
quarter of 2018.
- Continued Enrollment in ATTCK-20-03 Phase I
trial: In the fourth quarter of 2017, Unum initiated
patient enrollment in a Phase I, multi-center, open-label clinical
trial called ATTCK-20-03, evaluating the safety, tolerability, and
anti-lymphoma activity of ACTR707 used in combination with
rituximab in patients with CD20+ r/r NHL. Unum has completed
enrollment in the first dose level of this ongoing dose
escalation study and expects to report preliminary data from the
trial in the fourth quarter of 2018.
- On Track to File IND for First Solid Tumor ACTR Product
Candidate in the Second Half of 2018: Unum is on track to
file an IND in the second half of 2018 for ACTR707 in combination
with trastuzumab for the treatment of patients with HER2+ advanced
cancers.
First Quarter 2018 Financial Results
- Collaboration Revenue: Collaboration revenue
recognized during the three months ended March 31, 2018 and 2017,
of $2.2 million and $1.8 million, respectively, reflects
the recognition of a portion of the $25.0 million upfront
payment received from Seattle Genetics under Unum’s collaboration
agreement as well as reimbursements of research and development
costs by Seattle Genetics. Effective January 1, 2018, Unum
adopted the new revenue recognition standard, ASC 606, which
changed the manner in which the Company recognizes revenue from
this collaboration agreement.
- R&D Expenses: Research and
development expenses were $8.1 million for the three months
ended March 31, 2018, compared to $7.0 million for the same period
last year. The increase reflects higher clinical trial costs for
the three active Phase I clinical trials, as well as increased
personnel-related costs, materials and facility-related costs
related to scaling manufacturing processes, and increased
consultant costs. This was partially offset primarily by a decrease
in consulting and manufacturing costs incurred for the Phase I
clinical trial of ACTR087 in combination with rituximab as there
was no production activity in the first quarter of 2018.
- G&A Expenses: General and
administrative expenses for the three months ended March 31, 2018,
were $1.1 million, compared to $0.9 million for the prior
year period.
- Net Loss: Net loss attributable to common
stockholders was $6.8 million, or $0.66 per
share, for the three months ended March 31, 2018,
and $6.0 million, or $0.58 per share, for the
three months ended March 31, 2017.
- Cash, Cash Equivalents and Marketable
Securities: As of March 31, 2018, Unum had cash,
cash equivalents, and marketable securities of $32.4 million.
This amount does not include the approximately $66.8 million
in net proceeds from its IPO in April 2018, $5.0 million from the
concurrent private placement, and available borrowings under its
loan and security agreement of $15.0 million. The Company
believes that the net proceeds from the IPO and concurrent private
placement, together with its existing cash, cash equivalents, and
marketable securities, will fund operating expenses and capital
expenditure requirements through at least December 2019, without
considering available borrowings under its loan and security
agreement.
About Unum Therapeutics
Unum Therapeutics is a clinical-stage biopharmaceutical
company focused on the development and commercialization of novel
immunotherapy products designed to harness the power of a patient’s
immune system to cure cancer. Unum’s novel proprietary technology,
antibody-coupled T cell receptor (ACTR), is a universal, engineered
cell therapy intended to be used in combination with a wide range
of tumor-specific antibodies to target different tumor types. Unum
is actively building a pipeline of product candidates composed of
ACTR T cells co-administered with antibodies for use in both
hematologic and solid tumor cancers. The Company is headquartered
in Cambridge, MA.
Forward looking Statements
This press release contains forward-looking statements.
Statements in this press release about our future expectations,
plans and prospects, including projections regarding future
revenues and financing performance, our long-term growth, the
anticipated timing of our clinical trials and regulatory filings,
the development of our product candidates, including the four lead
ACTR product candidates, 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. 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, 212-362-1200stephanie@sternir.com
Media Contact: Paul Kidwell,
617-680-1088paul.kidwell@unumrx.com
|
|
|
|
UNUM THERAPEUTICS INC. CONSOLIDATED STATEMENTS
OF OPERATIONS (unaudited) (in thousands, except
share and per share data) |
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2018 |
|
|
2017 |
|
|
|
|
|
Collaboration revenue |
|
$ |
2,220 |
|
|
$ |
1,827 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
|
8,142 |
|
|
|
6,952 |
|
General
and administrative |
|
|
1,064 |
|
|
|
944 |
|
Total
operating expenses |
|
|
9,206 |
|
|
|
7,896 |
|
Loss from
operations |
|
|
(6,986 |
) |
|
|
(6,069 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
Interest
income |
|
|
81 |
|
|
|
90 |
|
Other
income, net |
|
|
170 |
|
|
|
40 |
|
Total
other income, net |
|
|
251 |
|
|
|
130 |
|
Net
loss |
|
|
(6,735 |
) |
|
|
(5,939 |
) |
Accretion
of redeemable convertible preferred stock to redemption
value |
|
|
(16 |
) |
|
|
(16 |
) |
Net loss
attributable to common stockholders |
|
$ |
(6,751 |
) |
|
$ |
(5,955 |
) |
Net loss
per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.66 |
) |
|
$ |
(0.58 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
|
10,204,591 |
|
|
|
10,190,228 |
|
|
UNUM THERAPEUTICS INC. CONSOLIDATED BALANCE
SHEET DATA (unaudited) (in
thousands) |
|
|
|
|
|
|
|
|
|
|
|
March 31, 2018 |
|
|
December 31, 2017 |
|
Cash,
cash equivalents and marketable securities |
|
|
$ |
32,400 |
|
|
$ |
40,961 |
|
Working
capital |
|
|
|
12,267 |
|
|
|
31,189 |
|
Total
assets |
|
|
|
43,415 |
|
|
|
49,115 |
|
Redeemable convertible preferred stock |
|
|
|
77,167 |
|
|
|
77,151 |
|
Total
stockholders' deficit |
|
|
|
(61,269 |
) |
|
|
(48,846 |
) |
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