CytomX Therapeutics, Inc. (Nasdaq:CTMX), a clinical-stage
biopharmaceutical company developing investigational Probody™
therapeutics for the treatment of cancer, today reported full-year
2017 financial results and provided an operational update on the
company.
As of December 31, 2017, CytomX had cash, cash equivalents
and short-term investments of $374.1 million. Based upon its
current operating plan, the Company expects its existing capital
resources will be sufficient to fund operations into 2020.
“The CytomX team continued tremendous execution during 2017,
driving our transition to a clinical-stage company with the
initiation of Phase 1/2 studies for two wholly-owned and one
partnered program,” said Sean McCarthy, D.Phil., president and
chief executive officer of CytomX Therapeutics.
“During 2018, we expect initial data readouts from our
PD-L1-targeting Probody therapeutic, CX-072, and our
CD166-targeting Probody drug conjugate, CX-2009. We also expect to
initiate clinical studies for two additional programs this year,
resulting in five clinical-stage Probody therapeutic programs by
year end. Our deepening pipeline of innovative therapeutics has the
potential to make a meaningful difference in the lives of people
with cancer,” continued Dr. McCarthy.
2017 Business Highlights and Recent
Developments
PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical
Program
- CX-072 is a Probody therapeutic targeting PD-L1, a clinically-
and commercially-validated anti-cancer target.
- Enrollment began in January 2017 in PROCLAIM-CX-072, a Phase
1/2 clinical trial evaluating CX-072 as monotherapy and in
combination with Yervoy® (ipilimumab) or Zelboraf® (vemurafenib) in
patients with cancer.
- Enrollment is complete in the monotherapy dose escalation arm
evaluating CX-072 in patients with advanced unresectable solid
tumors or lymphomas (Part A).
- Preliminary data from Part A is expected to be presented
mid-2018.
- Patient enrollment was initiated at a single dose level in an
expansion cohort in an undisclosed cancer with known sensitivity to
PD-pathway inhibitors (Part D).
- Patient enrollment is ongoing in all other dose escalation arms
of the study:
- Monotherapy expansion in patients with PD-L1-positive tumors at
multiple dose levels (Part A2);
- Combination of CX-072 plus Yervoy® (ipilimumab) in patients
with advanced unresectable solid tumors or lymphomas (Part B);
- Combination of CX-072 plus Zelboraf® (vemurafenib) in patients
with V600E BRAF-positive melanoma (Part C).
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical
Program
- CX-2009 is a Probody drug conjugate (PDC) that targets CD166,
an antigen that is broadly and highly expressed in many types of
cancer.
- Patient enrollment continues in the PROCLAIM-CX-2009 study, a
Phase 1/2 clinical trial initiated in June 2017, evaluating CX-2009
as monotherapy in a subset of CD166-positive cancer types (Part A).
- Preliminary data from Part A is expected to be presented in the
second half of 2018.
- Monotherapy expansion at select dose levels and in the same
subset of cancers has been initiated in patients selected for the
highest levels of CD166 expression (Part A2).
BMS-986249 (CTLA-4 Probody Therapeutic) Clinical
Program
- Bristol-Myers Squibb (BMS) presented preclinical safety and
anti-tumor activity data for an anti-CTLA-4 Probody therapeutic
designed to be a potentially safer ipilimumab.
- In fourth quarter of 2017, BMS initiated a Phase 1/2 study
evaluating BMS-986249 alone and in combination with nivolumab in
solid tumors that are advanced and have spread.
- BMS-986249 is the first Probody therapeutic to advance to the
clinic under the companies’ strategic collaboration.
CX-2029 (CD71 Probody Drug Conjugate) Preclinical
Program
- CytomX, in collaboration with AbbVie, is advancing
CX-2029, a CD71-directed PDC, through Investigational New Drug
(IND) application-enabling studies.
- CD71, also known as the transferrin receptor 1 (TfR1), is
highly expressed in a number of solid and hematologic cancers and
has particularly attractive molecular properties for efficient
delivery of cytotoxic payloads to tumor cells.
- CytomX expects to file an IND application for CX-2029 in the
first half of 2018.
CX-188 (PD-1 Probody Therapeutic) Preclinical
Program
- CytomX is advancing CX-188, a PD-1-directed Probody
therapeutic, through IND-enabling studies.
- PD-1 is the receptor for the PD-L1 ligand responsible for
inhibiting T-cell activation in a variety of cancers and is a
clinically- and commercially-validated anti-cancer target.
- CytomX expects to file an IND application for CX-188 in the
second half of 2018.
Partnerships
AbbVie Partnership
- During the third quarter of 2017, CytomX received a $15
million milestone payment ($14 million net of associated
license fees) from AbbVie in conjunction with meeting
certain criteria allowing the initiation of GLP toxicology studies
by CytomX for CX-2029, a CD71-directed PDC.
Amgen Partnership
- During the third quarter of 2017, Amgen and CytomX entered
into a strategic collaboration in immuno-oncology in the field of
Probody T-cell engaging bispecific antibodies (Pro-TCBs), including
the co-development of a CytomX Pro-TCB against the Epidermal Growth
Factor Receptor (EGFR), a highly validated oncology target
expressed on multiple human cancer types.
- Under the terms of the agreement, Amgen and CytomX
will co-develop a Pro-TCB against EGFR-CD3 with CytomX leading
early development.
- Amgen will lead later development and commercialization
with global late-stage development costs shared between the two
companies.
- Amgen made an upfront payment of $40 million and
purchased $20 million of CytomX common stock.
- CytomX is eligible to receive up to $455 million in
development, regulatory and commercial milestones payments for the
EGFR program and low-double digit to mid-teen percentage royalty
payments on resulting EGFR products, and has the ability to opt
into a profit share in the U.S.
- Amgen is also able to select three additional targets for
Pro-TCB discovery and development. Should Amgen ultimately pursue
all of these targets, CytomX will be eligible to receive up to $950
million in additional upfront and milestone payments and
high-single digit to low-teen percentage royalty payments on any
resulting products.
- CytomX also received the rights from Amgen to an undisclosed
preclinical T-cell engaging bispecific program; Amgen is eligible
to receive milestones and mid-single digit to low-double digit
percentage royalty payments on any resulting products from this
CytomX program.
Bristol-Myers Squibb Collaboration
Expansion
- During the second quarter of 2017, CytomX and BMS expanded its
foundational alliance to discover, develop and commercialize novel
therapies using the Probody platform, resulting in a $200
million upfront payment to CytomX.
- The expanded collaboration now provides BMS with the selection
of up to ten oncology targets and two non-oncology targets.
- In the fourth quarter of 2017, CytomX earned a $10 million
milestone payment from BMS upon IND clearance of BMS-986249.
Pfizer Collaboration
- On March 6, 2018, CytomX received notification of Pfizer’s
intent to terminate the companies’ research collaboration, option
and license agreement.
- The Pfizer collaboration, entered into in 2013, included the
selection of up to four PDC targets for the treatment of
cancer.
- The initial PDC target was EGFR, which Pfizer previously
discontinued, with certain rights reverting to CytomX.
- Collaboration programs against the second and third targets
were terminated during the first quarter of 2018.
- Pfizer had previously declined its option to select a fourth
target in the collaboration.
- None of the programs in the Pfizer collaboration had advanced
to clinical candidate stage.
Full-Year Financial ResultsCash, cash
equivalents and investments totaled $374.1 million as of December
31, 2017, compared to $181.9 million as of December 31, 2016. The
increase reflects cash provided by operations resulting primarily
from the $200 million of upfront payments received from BMS for
alliance expansion, $40 million of upfront payments and $20 million
of proceeds from stock sold as part of the Amgen agreement, and the
$15 million milestone payment ($14 million net of associated
license fees) received from AbbVie. These cash receipts were
partially offset by cash used to fund operations.
Research and development expenses were $92.3 million for the
year ended December 31, 2017, compared to $54.8 million for the
corresponding period in 2016. The increase in research and
development expenses was primarily attributable to a non-cash
charge of $10.7 million of in-process research and development
expense recognized related to the Amgen agreement; $10.0 million
sublicense payment made to UCSB triggered by the $200.0 million
upfront payment made by BMS in connection with our expanded
collaboration; $2.1 million of UCSB sublicense fees accrued as a
result of the Amgen agreement; $1.0 million of UCSB sublicense fees
recognized for our achievement of certain milestones required to be
met to begin GLP toxicology studies under the AbbVie agreement and
the IND filing for the CTLA-4 directed Probody therapeutic by BMS;
an increase of $8.5 million in pharmacology studies and clinical
trial expenses resulting from the advancement of CX-072, CX-2009,
and CX-2029 in 2017; an increase of $5.3 million in
personnel-related expenses and allocation of IT and
facilities-related expenses due to an increase in headcount; and an
increase of $1.7 million in consulting expenses due to the
commencement of clinical trials in 2017. These increases were
partially offset by a decrease of $2.1 million in manufacturing
expenses for our CX-072 and CX-2009 programs due to manufacturing
activities occurring in 2016 in preparation for clinical trials in
2017.
General and administrative expenses were $25.6 million for the
year ended December 31, 2017, compared to $19.9 million for the
year ended December 31, 2016. The increase was predominantly due to
an increase of $1.4 million in personnel-related expenses and an
increase of $1.0 million in recruitment fees due to an increase in
headcount and temporary labor; an increase in stock-based
compensation of $1.0 million due to an increase in headcount and an
increase in the value of our stock; and an increase of $1.2 million
in consulting services expenses primarily due to an increase in tax
and accounting compliance activities and investor relations
expenses.
Teleconference Scheduled Today at 5:00 p.m.
ETConference Call/Webcast
Information CytomX management will
host a conference call today at 5:00 p.m. ET. Interested
parties may access the live audio webcast of the teleconference
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 5686339. A replay will be available on the
CytomX website or by dialing 1-855-859-2056 and using the passcode
5686339. The replay will be available from March 7,
2018, until March 14, 2018.
About CytomX Therapeutics CytomX
Therapeutics is a clinical-stage biopharmaceutical company
with a deep and differentiated oncology pipeline of investigational
Probody™ therapeutics. Probody therapeutics are designed to 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 cancer
immunotherapies against clinically-validated targets, such as
CX-072, a PD-L1-targeting Probody therapeutic wholly owned by
CytomX, and BMS-986249, a CTLA-4-targeting Probody therapeutic
partnered with Bristol Myers Squibb. The pipeline also includes
first-in-class Probody drug conjugates against highly attractive
targets, such as CX-2009, a CD166-targeting Probody drug conjugate
wholly owned by CytomX, and CX-2029, a CD71-targeting Probody drug
conjugate partnered with AbbVie, 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, Amgen, Bristol-Myers Squibb
Company and ImmunoGen, Inc. For more information,
visit www.cytomx.com or follow us on Twitter.
CytomX Therapeutics Forward-Looking Statements
This 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 benefits and efficacy of CytomX’s or any of its
collaborative partners’ 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, the timing of any
future clinical trials to be initiated by CytomX or any of its
collaborative partners, CytomX’s expectations regarding the
availability of clinical data, CytomX’s expectations with respect
to its collaborations, and CytomX’s expectations regarding the
timing of potential regulatory filings. Risks and uncertainties
that contribute to the uncertain nature of the forward-looking
statements include: two of CytomX’s product candidates under its
Probody platform are in the initial stages of clinical development
and its 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; the possibility
that the results of early clinical trials may not be predictive of
future results; the possibility that CytomX’s clinical trials will
not be successful; CytomX’s dependence on the success of CX-072;
CytomX’s reliance on third parties for the manufacture of the
company’s product candidates; and possible regulatory developments
in the United States and foreign countries. 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. Additional 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 Annual Report
on Form 10-K filed with the SEC on March 7, 2018. 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.STATEMENTS
OF OPERATIONS AND COMPREHENSIVE LOSS(in thousands, except
share and per share data) |
|
|
|
|
|
Year Ended December 31, |
|
|
|
2017 |
|
|
2016 |
|
|
2015 |
|
Revenues |
|
$ |
71,623 |
|
|
$ |
12,845 |
|
|
$ |
5,941 |
|
Revenues from related
parties |
|
|
— |
|
|
|
2,198 |
|
|
|
1,771 |
|
Total
revenues |
|
|
71,623 |
|
|
|
15,043 |
|
|
|
7,712 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
92,277 |
|
|
|
54,755 |
|
|
|
28,357 |
|
General
and administrative |
|
|
25,605 |
|
|
|
19,874 |
|
|
|
12,558 |
|
Total
operating expenses |
|
|
117,882 |
|
|
|
74,629 |
|
|
|
40,915 |
|
Loss from
operations |
|
|
(46,259 |
) |
|
|
(59,586 |
) |
|
|
(33,203 |
) |
Interest
income |
|
|
2,674 |
|
|
|
736 |
|
|
|
1,315 |
|
Interest
expense |
|
|
— |
|
|
|
— |
|
|
|
(1,732 |
) |
Other
income (expense), net |
|
|
(27 |
) |
|
|
(69 |
) |
|
|
(1,744 |
) |
Loss before provision
for (benefit from) income taxes |
|
|
(43,612 |
) |
|
|
(58,919 |
) |
|
|
(35,364 |
) |
Provision
for (benefit from) income taxes |
|
|
(513 |
) |
|
|
(19 |
) |
|
|
10 |
|
Net loss |
|
|
(43,099 |
) |
|
|
(58,900 |
) |
|
|
(35,374 |
) |
Accretion to redemption
value and cumulative dividends on preferred stock |
|
|
— |
|
|
|
— |
|
|
|
(6,705 |
) |
Net loss attributable
to common stockholders |
|
$ |
(43,099 |
) |
|
$ |
(58,900 |
) |
|
$ |
(42,079 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(1.16 |
) |
|
$ |
(1.63 |
) |
|
$ |
(4.90 |
) |
Shares used to compute
net loss per share attributable to common stockholders, basic
and diluted |
|
|
37,166,830 |
|
|
|
36,234,732 |
|
|
|
8,595,247 |
|
Other comprehensive
loss: |
|
|
|
|
|
|
|
|
|
|
|
|
Changes
in unrealized gain (losses) on investments |
|
|
(67 |
) |
|
|
49 |
|
|
|
(76 |
) |
Comprehensive loss |
|
$ |
(43,166 |
) |
|
$ |
(58,851 |
) |
|
$ |
(35,450 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
CYTOMX THERAPEUTICS, INC.BALANCE
SHEETS(in thousands, except share and per share
data) |
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
177,548 |
|
|
$ |
104,645 |
|
Short-term investments |
|
|
196,562 |
|
|
|
77,293 |
|
Accounts
receivable |
|
|
10,139 |
|
|
|
2,159 |
|
Related
party accounts receivable |
|
|
— |
|
|
|
154 |
|
Prepaid
expenses and other current assets |
|
|
4,352 |
|
|
|
3,896 |
|
Total current
assets |
|
|
388,601 |
|
|
|
188,147 |
|
Property and equipment,
net |
|
|
4,218 |
|
|
|
4,392 |
|
Intangible assets,
net |
|
|
1,604 |
|
|
|
1,750 |
|
Goodwill |
|
|
949 |
|
|
|
949 |
|
Restricted cash |
|
|
917 |
|
|
|
917 |
|
Other assets |
|
|
1,355 |
|
|
|
2,973 |
|
Total assets |
|
$ |
397,644 |
|
|
$ |
199,128 |
|
Liabilities,
Convertible Preferred Stock and Stockholders' Equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
4,205 |
|
|
$ |
6,596 |
|
Accrued
liabilities |
|
|
16,383 |
|
|
|
8,824 |
|
Deferred
revenues, current portion |
|
|
40,559 |
|
|
|
20,347 |
|
Total current
liabilities |
|
|
61,147 |
|
|
|
35,767 |
|
Deferred revenue, net
of current portion |
|
|
264,704 |
|
|
|
83,803 |
|
Deferred tax
liability |
|
|
— |
|
|
|
513 |
|
Other long-term
liabilities |
|
|
1,897 |
|
|
|
566 |
|
Total liabilities |
|
|
327,748 |
|
|
|
120,649 |
|
Stockholders'
equity: |
|
|
|
|
|
|
|
|
Convertible preferred
stock, $0.00001 par value; 10,000,000 shares authorized at
December 31, 2017 and 2016; no shares issued and outstanding
at December 31, 2017 and 2016, respectively |
|
|
— |
|
|
|
— |
|
Common stock, $0.00001
par value; 75,000,000 shares authorized at December 31, 2017
and 2016; 38,478,560 and 36,490,169 shares issued and
outstanding at December 31, 2017 and 2016, respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
289,454 |
|
|
|
254,871 |
|
Accumulated other comprehensive loss |
|
|
(94 |
) |
|
|
(27 |
) |
Accumulated deficit |
|
|
(219,465 |
) |
|
|
(176,366 |
) |
Total stockholders'
equity |
|
|
69,896 |
|
|
|
78,479 |
|
Total liabilities,
convertible preferred stock and stockholders' equity |
|
$ |
397,644 |
|
|
$ |
199,128 |
|
|
|
|
|
|
|
|
|
|
CytomX Therapeutics Media: Spectrum
Christine Quern cquern@spectrumscience.com 202-587-2588
Investors: Trout Group Pete Rahmer prahmer@troutgroup.com
646-378-2973
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