OncoMed Announces Second Quarter 2018 Financial Results and Operational Highlights
August 02 2018 - 8:00AM
-Company prioritizes its navicixizumab resources
in platinum-resistant ovarian cancer; prepares to share data in Q4
of 2018-
OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage
biopharmaceutical company focused on discovering and developing
novel anti-cancer therapeutics, today announced second quarter 2018
financial results and provided a corporate update. As of June 30,
2018, cash, cash equivalents, and short-term investments totaled
$79.9 million.
"The first half of the year has been focused on effective
execution in the development of our pipeline of oncology
candidates, including navicixizumab, etigilimab (anti-TIGIT) and
GITRL-Fc which are being investigated in ongoing clinical trials,”
said John Lewicki, Ph.D., President and Chief Executive Officer of
OncoMed. “These activities will culminate in important data
announcements later this year. We are particularly encouraged by
the potential of navicixizumab, our lead product candidate, in the
treatment of late-stage ovarian cancer and look forward to sharing
single-agent and chemotherapy combination data by the end of the
year. We also plan to report first-in-human dose escalation Phase
1a data from our etigilimab program in the fourth quarter of 2018,
while early clinical data from our GITRL-Fc program will likely be
available in the first half of 2019.”
Pipeline Highlights
Navicixizumab (anti-DLL4/VEGF bispecific; OMP-305B83)
- An abstract summarizing interim Phase 1b clinical trial data of
navicixizumab in combination with paclitaxel for the treatment of
heavily pretreated, platinum-resistant ovarian cancer patients has
been accepted as a poster presentation on October 20, 2018 at the
European Society for Medical Oncology meeting in Munich, Germany.
In addition, the company expects to publish the final results of
the Phase 1a single-agent navicixizumab study in all-comers solid
tumor patients, which included several late-stage ovarian cancer
patients, by the end of 2018.
- The company has decided to prioritize navicixizumab development
resources in platinum-resistant ovarian cancer, where it believes
navicixizumab offers promise and potential as a meaningful
therapeutic for patients who lack effective later-line therapeutic
alternatives. Consequently, OncoMed has decided to discontinue
enrollment of additional patients in its Phase 1b trial of
navicixizumab in combination with FOLFIRI or FOLFOX in second-line
colorectal cancer as it pursues expanded development in ovarian
cancer. The Phase 1b ovarian cancer trial was recently expanded
from 30 patients to enroll up to 60 patients.
Etigilimab (Anti-TIGIT; OMP-313M32)
- In the second quarter, OncoMed initiated the Phase 1b portion
of the Phase 1a/b study of etigilimab in combination with anti-PD1
(nivolumab) in patients with advanced or metastatic solid tumors.
The company also completed dose-escalation in the Phase 1a portion
of the trial and is now enrolling patients in the single-agent
expansion phase of this study. The company expects to report data
from the Phase 1a dose-escalation portion of the trial, designed to
assess safety and tolerability of escalating doses of etigilimab
monotherapy, in the fourth quarter of 2018.
GITRL-Fc (OMP-336B11)
- Enrollment continues in the Phase 1a single-agent study of
OncoMed’s wholly-owned GITRL-Fc in patients with advanced or
metastatic solid tumors. 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.
Second Quarter 2018 Financial Results
Cash, cash equivalents and short-term
investments totaled $79.9 million as of June 30, 2018,
compared to $103.1 million as of December 31, 2017.
Revenues were $6.9 million for the second
quarter of 2018, an increase of $0.7 million, compared to $6.2
million for the same period in 2017. The change in revenue was a
result of the new revenue recognition standard adopted in the first
quarter of 2018.
Research and development (R&D)
expenses were $8.1 million for the second quarter of
2018, a decrease of $7.0 million, compared to $15.1 million for the
same period in 2017. The decrease in R&D expenses was due
to decreases in clinical development costs and reduced headcount as
a result of the restructuring actions in April 2017.
General and administrative (G&A)
expenses were $3.7 million for the second quarter of
2018, a decrease of $0.4 million, compared to $4.1 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 loss was $4.0 million ($0.10 per share) for
the second quarter of 2018, compared to $15.2 million ($0.40 per
share) for the same period of 2017. The change in
year-over-year net loss was primarily due to lower operating
expenses in the second quarter of 2018.
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.
Navicixizumab (anti-DLL4/VEGF bispecific, OMP-305B83), etigilimab
(anti-TIGIT, OMP-313M32), and rosmantuzumab (anti-RSPO3,
OMP-131R10) are part of OncoMed's strategic alliance with Celgene
Corporation. OncoMed is independently developing GITRL-Fc
(OMP-336B11), as well as continuing 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; navicixizumab’s promise and potential as a treatment for
late-stage ovarian cancer; and the timing of the availability and
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
August 2, 2018, and OncoMed's other current and periodic reports
filed with the SEC.
Contacts: Sylvia Wheeler
sylvia.wheeler@oncomed.com 650-995-8234
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 |
|
|
June 30, |
|
June 30, |
|
|
|
|
|
|
|
|
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue: |
$ |
6,870 |
|
|
$ |
6,195 |
|
|
$ |
14,719 |
|
|
$ |
12,408 |
|
|
|
|
|
|
|
|
|
|
| Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
8,054 |
|
|
|
15,090 |
|
|
|
16,441 |
|
|
|
39,077 |
|
|
General and administrative |
|
3,704 |
|
|
|
4,097 |
|
|
|
9,098 |
|
|
|
9,081 |
|
|
Restructuring charges |
|
— |
|
|
|
2,443 |
|
|
|
— |
|
|
|
2,443 |
|
|
Total operating expenses |
|
11,758 |
|
|
|
21,630 |
|
|
|
25,539 |
|
|
|
50,601 |
|
|
Loss from operations |
|
(4,888 |
) |
|
|
(15,435 |
) |
|
|
(10,820 |
) |
|
|
(38,193 |
) |
|
Interest and other income, net |
|
524 |
|
|
|
214 |
|
|
|
887 |
|
|
|
368 |
|
|
Loss before income taxes |
|
(4,364 |
) |
|
|
(15,221 |
) |
|
|
(9,933 |
) |
|
|
(37,825 |
) |
|
Income tax provision (benefit) |
|
(388 |
) |
|
|
4 |
|
|
|
(383 |
) |
|
|
8 |
|
|
Net loss |
$ |
(3,976 |
) |
|
|
(15,225 |
) |
|
$ |
(9,550 |
) |
|
|
(37,833 |
) |
|
Net loss per common share, basic and diluted |
$ |
(0.10 |
) |
|
$ |
(0.40 |
) |
|
$ |
(0.25 |
) |
|
$ |
(1.01 |
) |
| Shares used to compute for net loss per common share,
basic and diluted |
38,389,626 |
|
37,623,751 |
|
38,316,914 |
|
37,448,342 |
| |
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
| ONCOMED PHARMACEUTICALS,
INC. |
|
| Condensed Balance
Sheets |
|
| (Unaudited) |
|
| (In thousands) |
|
| |
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
June 30, 2018 |
|
December 31,
2017 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
| Cash, cash equivalents and short-term
investments |
$ |
79,866 |
|
$ |
103,091 |
|
|
| Prepaid and other assets |
|
|
|
|
6,043 |
|
|
7,231 |
|
|
| Total assets |
|
|
|
|
$ |
85,909 |
|
$ |
110,322 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Deferred revenue |
|
|
|
|
$ |
30,796 |
|
$ |
143,838 |
|
|
| Other liabilities |
|
|
|
|
|
11,138 |
|
|
15,087 |
|
|
| Stockholders' equity (deficit) |
|
|
|
|
43,975 |
|
|
(48,603 |
) |
|
| Total liabilities and stockholders' equity
(deficit) |
|
$ |
85,909 |
|
$ |
110,322 |
|
|
| |
|
|
|
|
|
|
|
|
|
|
|
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