Strong Pipeline Momentum
Continues
CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical
company developing investigational Probody™ therapeutics for the
treatment of cancer, today reported second quarter 2017 financial
results.
As of June 30, 2017, CytomX had cash, cash equivalents and
short-term investments of $335.9 million. Based upon its current
operating plan, the Company expects its existing capital resources
will be sufficient to fund operations into 2020.
“During the second quarter, our pipeline of innovative Probody
therapeutics continued to advance. We now have two wholly owned
product candidates in clinical studies - CX-072, a PD-L1-targeting
Probody therapeutic, and CX-2009, a Probody drug conjugate that
targets the novel, highly expressed tumor antigen, CD-166,” said
Sean McCarthy, D.Phil., president and chief executive officer of
CytomX Therapeutics. "We remain on track to disclose data from
these initial Probody clinical trials in 2018, and also expect
clinical trial initiation for two partnered programs during this
timeframe.”
Q2’17 BUSINESS HIGHLIGHTS AND RECENT
DEVELOPMENTS
PROCLAIM-CX-072 (PD-L1 Probody) Clinical
Program
- Patient enrollment has progressed well in the monotherapy dose
escalation arm of the study evaluating CX-072 in patients with
advanced unresectable solids tumors or lymphomas. This arm was
initiated in 1Q’17 and enrollment is expected to be completed in 2H
’17.
- Patient enrollment has been initiated in a combination arm of
the study evaluating a concomitant schedule for CX-072 plus
ipilimumab in patients with advanced unresectable solids tumors or
lymphomas.
- Patient enrollment has also been initiated in a vemurafenib
combination arm, evaluating CX-072 plus vemurafenib in patients
with V600E BRAF-positive melanoma.
- During the first half of 2018, an expansion cohort of the study
at the recommended Phase 2 dose is expected to begin enrolling
patients to evaluate CX-072 as monotherapy in a tumor type with
known sensitivity to PD-L1 and/or PD-1 inhibitors.
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical
Program
- Patient enrollment is underway in the PROCLAIM-CX-2009 study, a
Phase 1/2 clinical trial evaluating CX-2009 as monotherapy in a
subset of CD166-positive cancers.
- CX-2009 is a first-in-class Probody drug conjugate (PDC) that
targets CD-166, an antigen that is broadly and highly expressed in
many types of cancers, but has been considered undruggable given
that it is also expressed in normal tissue.
- CX-2009 has broad potential across multiple solid tumor types
and is the first PDC to enter the clinic.
CX-2029 Preclinical Program (Co-Development Partnership
with AbbVie)
- CX-2029, a first-in-class PDC-targeting CD71 being developed by
CytomX in collaboration with AbbVie, was advanced into GLP
toxicology studies, resulting in a $15 million milestone
payment from AbbVie to CytomX to be received during the
3Q’17.
- CD71, otherwise known as the transferrin receptor, is a high
potential target, which, like CD166, has previously been considered
undruggable given its expression and function in normal
tissues.
- CytomX remains on track to file an IND for CX-2029 in
2018.
Bristol-Myers Squibb (BMS) Partnership
- BMS is progressing IND-enabling studies for
a CTLA-4-directed Probody therapeutic discovered within
the collaboration and expects to initiate a clinical trial in early
2018.
- During the second quarter, CytomX recognized receipt of a $200
million upfront payment under the previously announced expansion of
the Bristol-Myers Squibb worldwide collaboration.
- BMS selected its fifth target in the collaboration, the first
under the newly expanded agreement. BMS has now selected five of
ten available oncology targets.
Second Quarter Financial ResultsCash, cash
equivalents and investments totaled $335.9 million as of June 30,
2017, compared to $181.9 million as of December 31, 2016. The
increase reflects a $200 million upfront payment received from BMS
in connection with the expansion of the existing collaboration.
Revenue was $8.8 million for the three months ended June 30,
2017, compared to $3.1 million for the three months ended June 30,
2016. The increase was primarily attributable to recognized revenue
from the upfront payment received from BMS in connection with the
expansion of the existing collaboration.
Research and development expenses were $28.1 million for the
three months ended June 30, 2017, compared to $12.7 million for the
three months ended June 30, 2016. The increase was primarily
attributable to a $10.0 million sublicense payment made to UCSB,
which was triggered by the receipt of the $200 million upfront
payment from BMS in connection with the expanded collaboration, an
increase of $2.8 million to advance the Company’s CX-072 and
CX-2009 into Phase 1/2 clinical development, an increase of $1.0
million in milestone payments to UCSB triggered by the development
of CX-2009, an increase of $1.0 million in facilities-related
expenses, and an increase of $0.8 million in personnel-related
expenses due to an increase in headcount.
General and administrative expenses were $6.0 million for the
three months ended June 30, 2017, compared to $4.6 million for the
three months ended June 30, 2016. The increase was attributable to
$0.6 million in personnel-related expenses due to an increase in
headcount, an increase of $0.4 million in severance payment, and an
increase of $0.3 million in facilities-related expenses.
Conference Call/Webcast InformationIn
conjunction with today’s financial results announcement, the
Company will provide a mid-year update via webcast or
teleconference. Interested parties may access the live audio
webcast of the teleconference today at 5:00 p.m. ET through the
Investor and News page of CytomX's website
at http://ir.cytomx.com or by dialing 1-877-809-6037 and
using the passcode 61956517. A replay will be available on
the CytomX website or by dialing 1-855-859-2056 and using the
passcode 61956517. The replay will be available
from August 7, 2017, until August 14, 2017.
About CytomX Therapeutics CytomX Therapeutics
is a clinical-stage biopharmaceutical company with a deep and
differentiated oncology pipeline of Probody™ therapeutics. Probody
therapeutics exploit unique conditions of the tumor
microenvironment to more effectively localize antibody binding and
activity while limiting activity in healthy tissues. The Company’s
pipeline includes proprietary cancer immunotherapies against
clinically-validated targets, such as PD-L1, and first-in-class
Probody drug conjugates against highly attractive targets, such as
CD166 and CD71, which are considered to be inaccessible to
conventional antibody drug conjugates due to their presence on
healthy tissue. In addition to its wholly owned programs, CytomX
has strategic collaborations with AbbVie, Bristol-Myers
Squibb Company, Pfizer Inc., MD Anderson Cancer
Center and ImmunoGen, Inc. For more information,
visit www.cytomx.com or follow us on Twitter.
CytomX Therapeutics Forward-Looking
StatementsThis press release includes forward-looking
statements. Such forward-looking statements involve known and
unknown risks, uncertainties and other important factors that are
difficult to predict, may be beyond our control, and may cause the
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied in such statements. Accordingly, you should
not rely on any of these forward-looking statements, including
those relating to the potential efficacy of CytomX’s product
candidates, administered separately or in combination , CytomX’s
ability and the ability of its collaborative partners to develop
and advance product candidates into and successfully complete
clinical trials, including CytomX’s Phase 1/2 clinical trials of
CX-072 and CX-2009 and the timing of any future clinical trials to
be initiated by CytomX or any of its collaborative partners. Two of
our product candidates under our Probody platform are in the
initial stages of clinical development and our other product
candidates are currently in preclinical development, and the
process by which preclinical and clinical development could
potentially lead to an approved product is long and subject to
significant risks and uncertainties. Projected net cash utilization
and capital resources are subject to substantial risk of variance
based on a wide variety of factors that can be difficult to
predict. Applicable risks and uncertainties include those
relating to our preclinical research and development, clinical
development, and other risks identified under the heading "Risk
Factors" included in CytomX’s Quarterly Report on Form 10-Q filed
with the SEC on August 7, 2017. The forward-looking statements
contained in this press release are based on information currently
available to CytomX and speak only as of the date on which they are
made. CytomX does not undertake and specifically disclaims any
obligation to update any forward-looking statements, whether as a
result of any new information, future events, changed circumstances
or otherwise.
|
CYTOMX THERAPEUTICS, INC. |
CONDENSED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
8,283 |
|
|
$ |
2,539 |
|
|
$ |
19,459 |
|
|
$ |
4,322 |
|
Revenues from related
party |
|
|
469 |
|
|
|
555 |
|
|
|
946 |
|
|
|
995 |
|
Total
revenues |
|
|
8,752 |
|
|
|
3,094 |
|
|
|
20,405 |
|
|
|
5,317 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
28,076 |
|
|
|
12,705 |
|
|
|
42,652 |
|
|
|
26,070 |
|
General
and administrative |
|
|
6,049 |
|
|
|
4,647 |
|
|
|
11,740 |
|
|
|
9,687 |
|
Total
operating expenses |
|
|
34,125 |
|
|
|
17,352 |
|
|
|
54,392 |
|
|
|
35,757 |
|
Loss from
operations |
|
|
(25,373 |
) |
|
|
(14,258 |
) |
|
|
(33,987 |
) |
|
|
(30,440 |
) |
Interest
income, net |
|
|
357 |
|
|
|
195 |
|
|
|
594 |
|
|
|
332 |
|
Other
income (expense), net |
|
|
(174 |
) |
|
|
(110 |
) |
|
|
(54 |
) |
|
|
(91 |
) |
Loss before provision
for income taxes |
|
|
(25,190 |
) |
|
|
(14,173 |
) |
|
|
(33,447 |
) |
|
|
(30,199 |
) |
Provision
for income taxes |
|
|
26 |
|
|
|
3 |
|
|
|
26 |
|
|
|
6 |
|
Net loss |
|
$ |
(25,216 |
) |
|
$ |
(14,176 |
) |
|
$ |
(33,473 |
) |
|
$ |
(30,205 |
) |
Net loss per share,
basic and diluted |
|
$ |
(0.69 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.91 |
) |
|
$ |
(0.84 |
) |
Shares used to compute
net loss per share, basic and diluted |
|
|
36,780,897 |
|
|
|
36,113,363 |
|
|
|
36,660,548 |
|
|
|
36,088,393 |
|
CYTOMX THERAPEUTICS, INC. |
CONDENSED BALANCE SHEETS |
(in thousands, except share and per share
data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
272,860 |
|
|
$ |
104,645 |
|
Short-term investments |
|
|
63,056 |
|
|
|
77,293 |
|
Accounts
receivable |
|
|
158 |
|
|
|
2,159 |
|
Related
party accounts receivable |
|
|
27 |
|
|
|
154 |
|
Prepaid
expenses and other current assets |
|
|
4,579 |
|
|
|
3,896 |
|
Total current
assets |
|
|
340,680 |
|
|
|
188,147 |
|
Property and equipment,
net |
|
|
4,319 |
|
|
|
4,392 |
|
Intangible assets |
|
|
1,750 |
|
|
|
1,750 |
|
Goodwill |
|
|
949 |
|
|
|
949 |
|
Restricted cash |
|
|
917 |
|
|
|
917 |
|
Other assets |
|
|
3,240 |
|
|
|
2,973 |
|
Total assets |
|
$ |
351,855 |
|
|
$ |
199,128 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
6,364 |
|
|
$ |
6,596 |
|
Accrued
liabilities |
|
|
7,499 |
|
|
|
8,824 |
|
Deferred
revenues, current portion |
|
|
46,772 |
|
|
|
20,347 |
|
Total current
liabilities |
|
|
60,635 |
|
|
|
35,767 |
|
Deferred revenue, net
of current portion |
|
|
237,053 |
|
|
|
83,803 |
|
Deferred tax
liability |
|
|
539 |
|
|
|
513 |
|
Other long-term
liabilities |
|
|
1,391 |
|
|
|
566 |
|
Total liabilities |
|
|
299,618 |
|
|
|
120,649 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Preferred stock,
$0.00001 par value; 10,000,000 shares authorized and no shares
issued and outstanding at June 30, 2017 and December 31, 2016. |
|
|
— |
|
|
|
— |
|
Common stock, $0.00001
par value; 75,000,000 shares authorized; 36,839,342 and 36,490,169
shares issued and outstanding at June 30, 2017 and December 31,
2016, respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
262,185 |
|
|
|
254,871 |
|
Accumulated other comprehensive loss |
|
|
(110 |
) |
|
|
(27 |
) |
Accumulated deficit |
|
|
(209,839 |
) |
|
|
(176,366 |
) |
Total stockholders'
equity |
|
|
52,237 |
|
|
|
78,479 |
|
Total liabilities and
stockholders' equity |
|
$ |
351,855 |
|
|
$ |
199,128 |
|
Media Contact:
Spectrum
Christine Quern
cquern@spectrumscience.com
202-587-2588
Investor Contact:
Trout Group
Pete Rahmer
prahmer@troutgroup.com
646-378-2973
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