OncoMed Announces Third Quarter 2018 Financial Results and Operational Highlights
02 November 2018 - 7:05AM
-Company continues enrollment in Phase 1b
navicixizumab trial following encouraging single agent and interim
combination results in ovarian cancer;
OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage
biopharmaceutical company focused on discovering and developing
novel anti-cancer therapeutics, today announced third quarter 2018
financial results and provided a corporate update. As of September
30, 2018, cash, cash equivalents, and short-term investments
totaled $70.9 million.
"As anticipated, our development efforts have culminated in a
stream of data this year and set the stage for additional data flow
in 2019,” said John Lewicki, Ph.D., President and Chief Executive
Officer of OncoMed. “The efficacy of navicixizumab, both as a
single agent and in combination with chemotherapy, has been
impressive in patients with heavily pretreated, late stage
recurrent ovarian cancer. We continue to enroll additional patients
in our ongoing Phase 1b clinical trial as we consider the possible
next steps for this program. Concurrently, clinical investigation
and proof of concept continues for our other clinical candidates:
etigilimab (anti-TIGIT) and GITRL-Fc in metastatic solid tumor
settings.”
Pipeline Highlights
Navicixizumab (anti-DLL4/VEGF bispecific; OMP-305B83)
- In the third quarter, OncoMed reported publication of results
from its Phase 1a study of single-agent navicixizumab in patients
with refractory solid tumors in Investigational New Drugs. The
results showed that 19 of the 66 patients with various types of
refractory solid tumors had tumor shrinkage following treatment
with navicixizumab. Notably, 3 of the 12 (25%) heavily pretreated
ovarian cancer patients treated in the trial achieved a partial
response with single-agent navicixizumab therapy.
- In addition, the company announced interim results from its
Phase 1b clinical trial of navicixizumab in combination with weekly
paclitaxel in ovarian cancer patients who had received a median of
four prior therapies. In addition, all patients had previously
received paclitaxel and 69% had received bevacizumab. The results,
which were presented at the European Society of Medical Oncology
meeting, showed that 22 of the 26 patients (85%) treated with the
novel regimen experienced clinical benefit. Notably 11 of the 26
patients (42%) achieved a partial response, the GCIG CA-125
response rate was 61% and the median progression-free survival was
5.4 months (95% CI: 3.5-8.0 months). Historical response rates for
patients with heavily pretreated platinum-resistant ovarian cancer
treated with chemotherapy are typically 15% or less.
Etigilimab (Anti-TIGIT monoclonal antibody; OMP-313M32)
- Enrollment continues in the company’s Phase 1a/1b clinical
trial of etigilimab. Specifically, the company is continuing to
enroll patients with select tumor types in the single-agent
expansion phase of the study and is also enrolling patients who
have progressed on prior immunotherapy in the Phase 1b portion of
the trial with these patients being treated with etigilimab plus
anti-PD1 (nivolumab). Phase 1a data from the dose-escalation
portion of the trial, designed to assess safety and tolerability of
escalating doses of etigilimab monotherapy, will be reported at the
Society for Immunotherapy of Cancer meeting in a poster
presentation on Friday and Saturday, November 9 and 10, 2018 and in
a rapid oral presentation on Saturday, November 10, 2018 from
12:35-1:35 pm Eastern Time.
GITRL-Fc (OMP-336B11)
- Enrollment continues in the Phase 1a single-agent study of its
wholly-owned GITRL-Fc in patients with advanced or metastatic solid
tumors. The company is pleased that enrollment in this trial has
been robust to date. GITRL-Fc is a fusion protein with an Fc-linked
fully human trimer ligand and is designed to activate the
co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis
factor receptor-related protein) to enhance T-cell modulated immune
responses. Data from the Phase 1a trial are expected to be
presented in 2019.
Third Quarter 2018 Financial Results
Cash, cash equivalents and short-term
investments totaled $70.9 million as of September 30,
2018, compared to $103.1 million as of December 31, 2017.
Revenues were $19.5 million for the third
quarter of 2018, an increase of $14.4 million, compared to $5.1
million for the same period in 2017. The increase in revenue was
due to the Company’s adoption of Accounting Standards Codification
(ASC) Topic 606, Revenue from Contracts with Customers effective
January 1, 2018.
Research and development (R&D)
expenses were $10.0 million for the third quarter of
2018, a decrease of $2.2 million, compared to $12.2 million for the
same period in 2017. The decrease in R&D expenses was due to
decreases in clinical development costs and a decrease in personnel
cost, including stock-based compensation.
General and administrative (G&A)
expenses were $3.7 million for the third quarter of
2018, a decrease of $0.2 million, compared to $3.9 million for the
same period in 2017. The decrease in G&A expenses was primarily
due to a decrease in personnel cost, including stock-based
compensation.
Net income was $6.1 million ($0.16 net income
per share, basic and diluted) for the third quarter of 2018,
compared to a net loss of $10.7 million ($0.28 net loss per share,
basic and diluted) for the same period of 2017. The net income
in the third quarter of 2018 was primarily due to higher
collaboration revenue as a result of the new revenue recognition
accounting standard adopted on January 1, 2018 and lower operating
expenses.
2018 Financial Guidance
With resource reprioritization and additional cash management
measures, OncoMed's current cash runway has been extended by one
quarter and is now estimated to fund operations through at least
the fourth quarter of 2019, without taking into account future
potential milestone or opt-in payments from its partners. OncoMed
estimates 2018 operating cash burn to be less than $55 million,
before considering potential milestone or opt-in payments.
About OncoMed Pharmaceuticals OncoMed
Pharmaceuticals is a clinical-stage biopharmaceutical company
focused on discovering and developing novel anti-cancer
therapeutics. OncoMed has internally discovered a broad pipeline of
investigational drugs intended to address the fundamental biology
driving cancer's growth, resistance, recurrence and metastasis.
Product candidates in OncoMed’s portfolio include navicixizumab
(anti-DLL4/VEGF bispecific, OMP-305B83), etigilimab (anti-TIGIT,
OMP-313M32), and GITRL-Fc (OMP-336B11). OncoMed also continues to
pursue new drug discovery research. For further information about
OncoMed Pharmaceuticals, please see www.oncomed.com.
Forward Looking Statements To the extent that
statements contained in this press release are not descriptions of
historical facts regarding OncoMed Pharmaceuticals, they are
forward-looking statements reflecting the current beliefs and
expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
including, without limitation, OncoMed’s intentions and
expectations regarding the period of time during which cash will be
available to fund OncoMed's operations; OncoMed's cash burn for
2018; the enrollment of additional patients in OncoMed’s clinical
trials, including its navicixizumab clinical trial; the possible
next steps for the navicixizumab program; the efficacy of
navicixizumab in patients with ovarian cancer and, in particular,
heavily pre-treated, late-stage recurrent ovarian cancer; and the
timing of the reporting of data from OncoMed's clinical programs.
Such forward-looking statements involve substantial risks and
uncertainties that could cause OncoMed's clinical development
programs, future results, performance or achievements to differ
significantly from those expressed or implied by the
forward-looking statements. Such risks and uncertainties include,
among others, the uncertainties inherent in the preclinical and
clinical development process; OncoMed's ability to raise additional
capital to support the development of its unpartnered programs; and
OncoMed's dependence on its key executives. OncoMed undertakes no
obligation to update or revise any forward-looking statements. 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 OncoMed's
business in general, see OncoMed's Annual Report on Form 10-K filed
with the U.S. Securities and Exchange Commission (SEC) on March 9,
2018, OncoMed’s Quarterly Report on Form 10-Q filed with the SEC on
November 1, 2018, and OncoMed's other current and periodic reports
filed with the SEC.
Contacts:
Sylvia Wheeler Sylvia.wheeler@oncomed.com
Alex Santos asantos@wheelhouselsa.com
ONCOMED PHARMACEUTICALS, INC. |
|
Condensed Statements of
Operations |
|
(Unaudited) |
|
(In thousands, except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
|
September 30, |
|
September 30, |
|
|
|
|
|
|
|
|
|
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|
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
19,518 |
|
$ |
5,106 |
|
|
$ |
34,237 |
|
|
$ |
17,515 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
10,025 |
|
|
12,191 |
|
|
|
26,466 |
|
|
|
51,268 |
|
|
General
and administrative |
|
|
3,702 |
|
|
3,871 |
|
|
|
12,800 |
|
|
|
12,952 |
|
|
Restructuring charges |
|
|
— |
|
|
69 |
|
|
|
— |
|
|
|
2,513 |
|
|
Total
operating expenses |
|
|
13,727 |
|
|
16,131 |
|
|
|
39,266 |
|
|
|
66,733 |
|
|
Income
(loss) from operations |
|
|
5,791 |
|
|
(11,025 |
) |
|
|
(5,029 |
) |
|
|
(49,218 |
) |
|
Interest
and other income, net |
|
|
324 |
|
|
337 |
|
|
|
1,211 |
|
|
|
705 |
|
|
Income
(loss) before income taxes |
|
|
6,115 |
|
|
(10,688 |
) |
|
|
(3,818 |
) |
|
|
(48,513 |
) |
|
Income
tax provision (benefit) |
|
|
— |
|
|
4 |
|
|
|
(383 |
) |
|
|
12 |
|
|
Net
income (loss) |
|
$ |
6,115 |
|
$ |
(10,692 |
) |
|
$ |
(3,435 |
) |
|
$ |
(48,525 |
) |
|
Net income (loss) per common share, basic and diluted |
$ |
0.16 |
|
$ |
(0.28 |
) |
|
$ |
(0.09 |
) |
|
$ |
(1.29 |
) |
|
Shares
used to compute for net income (loss) per common share,
basic |
|
|
38,508,204 |
|
|
37,662,868 |
|
|
|
38,381,374 |
|
|
|
37,520,608 |
|
|
Shares
used to compute for net income (loss) per common share,
diluted |
|
|
38,512,526 |
|
|
37,662,868 |
|
|
|
38,381,374 |
|
|
|
37,520,608 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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ONCOMED PHARMACEUTICALS, INC. |
|
Condensed Balance Sheets |
|
(Unaudited) |
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30,
2018 |
|
December 31,
2017 |
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments |
|
|
|
|
|
$ |
70,856 |
|
|
$ |
103,091 |
|
|
Prepaid and other assets |
|
|
|
|
|
|
6,297 |
|
|
|
7,231 |
|
|
Total assets |
|
|
|
|
|
$ |
77,153 |
|
|
$ |
110,322 |
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue |
|
|
|
|
|
$ |
11,278 |
|
|
$ |
143,838 |
|
|
Other liabilities |
|
|
|
|
|
|
14,151 |
|
|
|
15,087 |
|
|
Stockholders' equity (deficit) |
|
|
|
|
|
|
51,724 |
|
|
|
(48,603 |
) |
|
Total liabilities and stockholders' equity
(deficit) |
|
|
|
|
|
$ |
77,153 |
|
|
$ |
110,322 |
|
|
|
|
|
|
|
|
|
|
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