CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage
oncology-focused biopharmaceutical company pioneering a novel class
of investigational antibody therapeutics based on its Probody™
therapeutic technology platform, today reported first quarter 2019
financial results.
As of March 31, 2019, CytomX had cash, cash equivalents and
short-term investments of $396.6 million.
“We continued to make excellent progress developing our
differentiated technology platform and lead product candidates
during the first quarter,” said Sean McCarthy, D.Phil., president,
chief executive officer and chairman of CytomX Therapeutics.
“Early clinical data from our PROCLAIM CX-072 and PROCLAIM-CX-2009
programs continued to emerge, pointing the way to next steps for
these unique assets. Taken together, the developing clinical
profiles for CX-072 and CX-2009 validate that the Probody platform
has potential to give rise to best in class and first-in-class
product candidates for the treatment of cancer. We look forward to
providing additional details regarding the advancement of our
pipeline as we progress through 2019.” 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.
- CytomX has previously presented Phase 1 clinical data from
PROCLAIM-CX-072 evaluating the safety and activity of CX-072 as
monotherapy and in combination with YERVOY® (ipilimumab).•
The PROCLAIM-CX-072 Monotherapy dose escalation phase is complete
(Parts A and A2). Of 24 efficacy evaluable patients, all with
generally weakly immunogenic tumors, and treated with doses greater
than or equal to 3 mg/kg of CX-072, 12 (50%) demonstrated tumor
shrinkage including four partial responses (one confirmed, 2
unconfirmed, one confirmation pending) as of the February 6, 2019
data cutoff. CX-072 as monotherapy was generally well
tolerated. A maximum tolerated dose (MTD) for CX-072 monotherapy
was not reached.• The PROCLAIM-CX-072 combination dose
escalation of CX-072 with ipilimumab (Part B1) is complete with the
MTD defined as 3 mg/kg of ipilimumab and 10 mg/kg of CX-072.
Of 19 patients evaluable for efficacy, four (21%) patients
experienced confirmed responses as of the February 6,
2019 data cutoff including one complete response. Among
27 patients treated with CX-072 in combination with ipilimumab at 3
mg/kg or above, the combination was generally well tolerated.
Seven (26%) patients reported a Grade 3/4 treatment-related adverse
event (TRAE) and 3 (11%) patients reported a Grade 3/4
immune-related adverse event (irAE). These data compare well
to historical controls and strongly support the further clinical
advancement of this combination.
- Updated clinical data from monotherapy expansion cohorts (Part
D) of the PROCLAIM-CX-072 program, evaluating the safety and
efficacy of CX-072 in multiple tumor types at 10mg/kg, will be
presented in a poster and as part of the Poster Discussion Session
on Saturday, June 1 at the 2019 Annual Society of Clinical Oncology
(ASCO) Annual Meeting.• Abstract 2513 - CX-072, a PD-L1
Probody Therapeutic, as Monotherapy in Patients with Advanced Solid
Tumors: Preliminary Results of PROCLAIM-CX-072
- Next steps in the further advancement of CX-072 are under
development.
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical
Program
- CX-2009 is a first in class Probody drug conjugate (PDC) that
targets CD166, a novel antigen that is broadly and highly expressed
in many types of cancer.
- During the first quarter, CytomX presented preliminary clinical
findings from PROCLAIM-CX-2009 studying CX-2009 as monotherapy in a
subset of CD166 expressing cancer types, including certain patients
selected for high level CD166 expression (Parts A and A2).•
As of a February 26, 2019 data snapshot, 71 patients at all doses
tested were evaluable for efficacy. For patients who received ≥4
mg/kg of CX-2009 and had at least one post-baseline, on-study tumor
assessment, 15/39 (38%) achieved tumor shrinkage, including seven
unconfirmed partial responses observed in breast cancer, ovarian
cancer and head and neck cancer. 29/39 patients (74%)
achieved stable disease or better at the time of the first
on-treatment scan.• CX-2009 was generally well tolerated. The
MTD was not reached at the highest dose level tested of 10 mg/kg.
The most common TRAEs were grade 1 and 2 and included nausea (32%),
fatigue (24%) and decreased appetite (23%). The most common grade
3/4 TRAE was keratitis (8%).
- Next steps in the further advancement of CX-2009 are under
development.
CX-2029 (CD71 Probody Drug Conjugate) Clinical
Program
- CD71, also known as the Transferrin Receptor, is a highly
efficient cellular mechanism for the internalization of antibody
drug conjugates in preclinical models.
- Given the widespread expression of CD71 on normal tissues,
however, it is widely considered to be an undruggable target for
clinical purposes using conventional antibody drug conjugate
technology.
- CytomX discovered and is developing, in collaboration with
AbbVie, CX-2029, a CD71-directed Probody Drug Conjugate which has
the potential to turn CD71 into a druggable target.
- CytomX continues to enroll patients in PROCLAIM-CX-2029, a
Phase 1/2 clinical trial evaluating CX-2029 as monotherapy in
patients with solid tumors or lymphomas.
BMS-986249 (CTLA-4 Probody Therapeutic) Clinical
Program
- Bristol-Myers Squibb (BMS), continues enrollment in a Phase 1/2
clinical trial evaluating BMS-986249 alone and in combination with
OPDIVO® (nivolumab) in solid tumors that are advanced and have
spread.
Technology Acquisition from Agensys, Inc.
- In January, CytomX announced the acquisition of drug conjugate
linker-toxin and CD3-based bispecific technologies from Agensys,
Inc., an affiliate of Astellas Pharma Inc. CytomX aims to utilize
this technology in the ongoing discovery and development of novel
Probody therapeutic candidates.
Appointment of New Director
- In April, CytomX announced the appointment of Elaine V. Jones,
Ph.D. to the Board of Directors, effective May 1, 2019.
First Quarter 2019 Financial Results
Cash, cash equivalents and short-term investments totaled $396.6
million as of March 31, 2019, compared to $436.1 million as of
December 31, 2018.
Revenue was $29.5 million for the three months ended March 31,
2019, compared to $14.2 million for the three months ended March
31, 2018. The increase in revenue of $15.3 million for the
current period compared to the corresponding period in 2018 was
primarily due to the accelerated recognition of revenue of $17.4
million related to the cessation of research on certain targets
under the BMS Agreement in 2019.
Research and development expenses increased by $13.9 million
during the three months ended March 31, 2019 compared to the
corresponding period in 2018. The increase was attributable
to a $5.0 million charge for acquired technical know-how related to
drug conjugate linker-toxin and CD3-based bispecific technologies
during the current period, an increase of $2.5 million expenses
related to laboratory contracts and services and laboratory
supplies and equipment, an increase of $2.1 million clinical
related expenses resulting from increased clinical trial activities
and an increase of $3.4 million in personnel-related expenses due
to an increase in headcount.
General and administrative expenses increased by $2.3 million
during the three months ended March 31, 2019 compared to the
corresponding period in 2018. The increase was attributable
to increased personnel-related expense due to an increase in
headcount, and increased consulting and professional services
primarily due to an increase in tax and accounting compliance
activities.
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 & News” section of
CytomX's website at http://ir.cytomx.com or by dialing
1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International)
and using the passcode 9496795. An archive of the webcast will be
available on the CytomX website from May 9, 2019, until May 16,
2019.
About CytomX Therapeutics
CytomX Therapeutics is a clinical-stage oncology-focused
biopharmaceutical company pioneering a novel class of
investigational antibody therapeutics based on its Probody™
therapeutic technology platform. Probody therapeutics are designed
to exploit unique conditions of the tumor microenvironment to more
effectively localize antibody binding and activity while minimizing
activity in healthy tissues. CytomX and its partners have four
programs in the clinic. The Company’s clinical stage pipeline
includes cancer immunotherapies against clinically validated
targets, including a PD-L1-targeting Probody therapeutic wholly
owned by CytomX (CX-072) and a CTLA-4-targeting Probody therapeutic
partnered with Bristol Myers Squibb (BMS-986249). The CytomX
clinical stage pipeline also includes first-in-class Probody drug
conjugates against highly attractive targets including a
CD166-targeting Probody drug conjugate wholly owned by CytomX
(CX-2009), and a CD71-targeting Probody drug conjugate partnered
with AbbVie (CX-2029). CD166 and CD71 are among cancer targets that
are considered to be inaccessible to conventional antibody drug
conjugates due to their presence on many healthy tissues. 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.
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. In particular, clinical and preclinical
data referenced above for CX-072 and CX-2009, including data on
efficacy and safety, including treatment related adverse events, is
based on a limited dataset, including for the clinical data, a
limited number of patients and at specific doses and, in some
cases, specific cancer types. Accordingly, you should not rely on
any of these forward-looking statements, including those relating
to the potential benefits, safety and efficacy of CytomX’s or any
of its collaborative partners’ product candidates, administered
separately or in combination, the potential benefits or
applications of CytomX’s Probody platform technology, CytomX’s
ability to develop and advance product candidates into and
successfully complete clinical trials, including the ongoing
clinical trials of CX-072 and CX-2009, and the timing of any
future clinical trials to be initiated by CytomX or its
collaborative partners. Risks and uncertainties that contribute to
the uncertain nature of the forward-looking statements include: the
unproven nature of CytomX’s novel Probody Platform technology; four
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, CX-2009,
CX-2029 and BMS 986249; 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. 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 Quarterly Report on Form 10-Q
filed with the SEC on May 9, 2019. 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 |
|
|
|
March 31, |
|
|
|
2019 |
|
|
2018 |
|
Revenues |
|
$ |
29,485 |
|
|
$ |
14,184 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
36,376 |
|
|
|
22,458 |
|
General and administrative |
|
|
9,674 |
|
|
|
7,356 |
|
Total operating expenses |
|
|
46,050 |
|
|
|
29,814 |
|
Loss from operations |
|
|
(16,565 |
) |
|
|
(15,630 |
) |
Interest income |
|
|
2,496 |
|
|
|
1,375 |
|
Other expense |
|
|
(61 |
) |
|
|
(140 |
) |
Loss before income taxes |
|
|
(14,130 |
) |
|
|
(14,395 |
) |
Provision for (benefit from) income taxes |
|
|
(6 |
) |
|
|
1,098 |
|
Net loss |
|
$ |
(14,124 |
) |
|
$ |
(15,493 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.31 |
) |
|
$ |
(0.40 |
) |
Shares used to compute net loss
per share, basic and diluted |
|
|
45,122,456 |
|
|
|
38,647,878 |
|
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
Changes in unrealized gain (loss) on short-term investments, net of
tax |
|
|
155 |
|
|
|
(134 |
) |
Impact of adoption of new accounting pronouncement |
|
|
11 |
|
|
|
— |
|
Comprehensive loss |
|
$ |
(13,958 |
) |
|
$ |
(15,627 |
) |
CYTOMX THERAPEUTICS,
INC.CONDENSED BALANCE SHEETS(in
thousands, except share and per share data)
|
|
March 31, |
|
|
December 31, |
|
|
2019 |
|
|
2018 |
|
|
(unaudited) |
|
|
(1) |
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
190,407 |
|
|
$ |
247,577 |
|
Short-term investments |
|
|
206,189 |
|
|
|
188,550 |
|
Accounts receivable |
|
|
44 |
|
|
|
97 |
|
Prepaid expenses and other current assets |
|
|
8,437 |
|
|
|
9,251 |
|
Total current assets |
|
|
405,077 |
|
|
|
445,475 |
|
Property and equipment, net |
|
|
7,369 |
|
|
|
6,934 |
|
Intangible assets, net |
|
|
1,422 |
|
|
|
1,458 |
|
Goodwill |
|
|
949 |
|
|
|
949 |
|
Restricted cash |
|
|
917 |
|
|
|
917 |
|
Operating lease right-of-use |
|
|
27,404 |
|
|
|
— |
|
Other assets |
|
|
1,375 |
|
|
|
1,375 |
|
Total assets |
|
$ |
444,513 |
|
|
$ |
457,108 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
|
$ |
9,511 |
|
|
$ |
5,132 |
|
Accrued liabilities |
|
|
22,567 |
|
|
|
26,724 |
|
Income tax payable |
|
|
13,374 |
|
|
|
13,339 |
|
Deferred revenue, current portion |
|
|
50,765 |
|
|
|
52,713 |
|
Total current liabilities |
|
|
96,217 |
|
|
|
97,908 |
|
Deferred revenue, net of current
portion |
|
|
197,754 |
|
|
|
225,267 |
|
Operating lease liabilities -
long term |
|
|
27,008 |
|
|
|
— |
|
Other long-term liabilities |
|
|
963 |
|
|
|
3,050 |
|
Total liabilities |
|
|
321,942 |
|
|
|
326,225 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
Convertible preferred stock,
$0.00001 par value; 10,000,000 shares authorized and no shares
issued and outstanding at March 31, 2019 and December 31,
2018. |
|
|
— |
|
|
|
— |
|
Common stock, $0.00001 par value;
75,000,000 shares authorized; 45,157,652 and 45,083,209 shares
issued and outstanding at March 31, 2019 and December 31, 2018,
respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
451,613 |
|
|
|
445,956 |
|
Accumulated other comprehensive income (loss) |
|
|
73 |
|
|
|
(93 |
) |
Accumulated deficit |
|
|
(329,116 |
) |
|
|
(314,981 |
) |
Total stockholders' equity |
|
|
122,571 |
|
|
|
130,883 |
|
Total liabilities and
stockholders' equity |
|
$ |
444,513 |
|
|
$ |
457,108 |
|
(1) The condensed balance sheet as of December
31, 2018 was derived from the audited financial statements included
in the Company's Annual Report on Form 10-K for the year ended
December 31, 2018.
CytomX TherapeuticsInvestors: Christopher
KeenanVP, Investor Relations and Corporate
Communicationsckeenan@cytomx.com650-383-0823
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