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 second quarter 2019
financial results.
As of June 30, 2019, CytomX had cash, cash equivalents and
short-term investments of $349.1 million.
“CytomX continues to make progress across its pipeline.
Highlights of the second quarter included additional presentations
of clinical data for our lead, wholly owned assets, CX-072 and
CX-2009, which further demonstrated the potential of these two
novel anti-cancer agents,” said Sean McCarthy, D.Phil., president,
chief executive officer and chairman of CytomX Therapeutics.
“Our clinical work to date with our lead programs provides
validation for our unique approach to targeting antibody therapies
to the tumor microenvironment and, accordingly, the discovery and
development of new and differentiated treatments for cancer
patients.”
Business Highlights and Recent Developments
PROCLAIM-CX-072 (PD-L1 Probody Therapeutic) Clinical
Program
- CX-072 is a wholly owned Probody therapeutic targeting PD-L1, a
clinically and commercially validated anti-cancer target.
- CytomX presented updated clinical data from monotherapy
expansion cohorts (Part D) of the PROCLAIM-CX-072 Phase 1/2 study,
evaluating the safety and efficacy of CX-072 in multiple tumor
types at 10 mg/kg at the 2019 Annual Society of Clinical Oncology
(ASCO) Annual Meeting. These data demonstrated a favorable safety
profile and evidence of anti-cancer activity in certain patients
with triple negative breast cancer, anal squamous cell carcinoma,
cutaneous squamous cell carcinoma and undifferentiated pleomorphic
sarcoma.
- David Page, M.D., Medical Oncologist, Providence Cancer Center
presented clinical data from PROCLAIM-CX-072 monotherapy and in
combination with ipilimumab (YERVOY®) as part of a Poster
Discussion Session at the 2019 ASCO Annual Meeting.
PROCLAIM-CX-2009 (CD166 Probody Drug Conjugate) Clinical
Program
- CX-2009 is a wholly owned, first in class Probody drug
conjugate (PDC) targeting CD166, a novel antigen that is broadly
and highly expressed in many types of cancer.
- CytomX reported preliminary data from the dose-escalation phase
(Part A and A2) of the ongoing PROCLAIM-CX-2009 Phase 1/2 study,
evaluating the safety and antitumor activity of CX-2009 in seven
selected tumor types, at the 2019 American Association for Cancer
Research (AACR) Annual Meeting. CX-2009 was generally well
tolerated. Single agent anti-cancer activity was observed in
certain patients with breast cancer, ovarian cancer and head and
neck cancer.
CX-2029 (CD71 Probody Drug Conjugate) Clinical
Program
- CX-2029 is a first in class PDC targeting CD71, the Transferrin
Receptor, a highly efficient cellular mechanism for the
internalization of antibody drug conjugates in preclinical
models.
- CD71 is widely expressed on normal tissues and therefore is
considered to be an undruggable clinical target for conventional
antibody drug conjugate technology.
- CytomX discovered and is developing CX-2029 in collaboration
with AbbVie to potentially turn CD71 into a druggable
target.
- CytomX continues to enroll patients in the PROCLAIM-CX-2029
Phase 1/2 study 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
dose escalation clinical study evaluating BMS-986249 alone and in
combination with OPDIVO® (nivolumab) in solid tumors that are
advanced and have spread.
- BMS is preparing to initiate the Phase 2 portion of this
clinical trial, upon which CytomX is entitled to a $10 million
milestone payment.
AbbVie Second Target Selection Under Strategic Oncology
Collaboration
- In July 2019, CytomX announced its partner AbbVie selected a
second target under the companies’ 2016 Discovery Collaboration and
Licensing Agreement to discover and develop Probody drug
conjugates. The target selection triggered a $10 million payment to
CytomX.
Second Quarter 2019 Financial ResultsCash, cash
equivalents and short-term investments totaled $349.1 million as of
June 30, 2019, compared to $436.1 million as of December 31,
2018. The decrease of $87.0 million for the six months ended
June 30, 2019 included certain infrequent payments such as $5.0
million for the acquisition from an Astellas subsidiary of
technical know-how related to drug conjugate linker-toxin and
CD3-based bispecific antibody technology in the first quarter, a
$13.7 million federal tax payment for the 2018 tax return filing in
the second quarter and approximately $4.7 million related to the
UCSB license agreement, also in the second quarter.
Revenue was $9.0 million for the three months ended June 30,
2019, compared to $21.3 million for the three months ended June 30,
2018. The decrease in revenue of $12.3 million for the three
months ended June 30, 2019 compared to the corresponding period in
2018 was primarily due to the $21.0 million milestone payment (net
of the associated sublicense fee of $4.0 million) earned in May
2018 under the CD71 Agreement with AbbVie, of which $9.9 million
was recognized in the second quarter of 2018 reflecting the
percentage completed-to-date of the project related to this
milestone.
Research and development expenses increased $5.3 million during
the three months ended June 30, 2019 compared to the corresponding
period in 2018. The increase was attributable to $3.4 million
in license fees and maintenance fees related to an amendment to the
UCSB Licensing Agreement (which included the issuance of 150,000
shares of Company common stock valued at $1.6 million, an upfront
payment of $1.0 million and an additional annual maintenance fee of
$0.8 million), an increase of $0.8 million sublicense expense
pertaining to the $10.0 million milestone payment earned upon the
AbbVie selection of the second target in the second quarter of 2019
under the Amended and Restated Discovery Collaboration and License
Agreement, an increase of $2.4 million in personnel-related
expenses due to an increase in headcount, an increase of $0.5
million in clinical related expenses resulting from increased
clinical trial activities and an increase of $0.7 million in the
allocation of information technology and facilities related
expenses resulting from an increase in headcount, partially offset
by a decrease of $2.3 million in laboratory contracts and services
as a result of timing of manufacturing activities.
General and administrative expenses increased by $0.4 million
during the three months ended June 30, 2019 compared to the
corresponding period in 2018. The increase was attributable to an
increase of $1.0 million in personnel-related expenses due to an
increase in headcount, an increase of $0.3 million for dues and
subscriptions primarily related to software and other IT services
and an increase of $0.2 million in professional service expenses,
partially offset by a decrease of $0.5 million in consulting and
contract services and a decrease of $0.7 million through increased
expense allocation of information technology and facilities-related
expenses to research and development due to an increase in research
and development headcount.
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 7785617. An archive of the
webcast will be available on the CytomX website from August 7,
2019, until August 21, 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, 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 August 7, 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.
YERVOY and OPDIVO are registered trademarks of Bristol-Myers
SquibbPROBODY is a trademark of CytomX Therapeutics
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, |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
Revenues |
|
$ |
9,013 |
|
|
$ |
21,338 |
|
|
$ |
38,498 |
|
|
$ |
35,522 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
30,835 |
|
|
|
25,553 |
|
|
|
67,211 |
|
|
|
48,011 |
|
General and administrative |
|
|
9,411 |
|
|
|
9,042 |
|
|
|
19,085 |
|
|
|
16,398 |
|
Total operating expenses |
|
|
40,246 |
|
|
|
34,595 |
|
|
|
86,296 |
|
|
|
64,409 |
|
Loss from operations |
|
|
(31,233 |
) |
|
|
(13,257 |
) |
|
|
(47,798 |
) |
|
|
(28,887 |
) |
Interest income |
|
|
2,361 |
|
|
|
1,540 |
|
|
|
4,856 |
|
|
|
2,915 |
|
Other income (expense), net |
|
|
(88 |
) |
|
|
61 |
|
|
|
(149 |
) |
|
|
(79 |
) |
Loss before income taxes |
|
|
(28,960 |
) |
|
|
(11,656 |
) |
|
|
(43,091 |
) |
|
|
(26,051 |
) |
Provision for (benefit from) income taxes |
|
|
— |
|
|
|
1,791 |
|
|
|
(6 |
) |
|
|
2,889 |
|
Net loss |
|
$ |
(28,960 |
) |
|
$ |
(13,447 |
) |
|
$ |
(43,085 |
) |
|
$ |
(28,940 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.64 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.95 |
) |
|
$ |
(0.75 |
) |
Shares used to compute net loss
per share, basic and diluted |
|
|
45,340,023 |
|
|
|
38,961,021 |
|
|
|
45,231,239 |
|
|
|
38,805,317 |
|
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Changes in unrealized gain (loss) on short-term investments, net of
tax |
|
|
136 |
|
|
|
50 |
|
|
|
291 |
|
|
|
(84 |
) |
Impact of adoption of new accounting pronouncement |
|
|
— |
|
|
|
— |
|
|
|
11 |
|
|
|
— |
|
Comprehensive loss |
|
$ |
(28,824 |
) |
|
$ |
(13,397 |
) |
|
$ |
(42,783 |
) |
|
$ |
(29,024 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
CYTOMX THERAPEUTICS,
INC.CONDENSED BALANCE SHEETS(in
thousands, except share and per share data)
|
|
June 30, |
|
|
December 31, |
|
|
|
2019 |
|
|
2018 |
|
|
|
(unaudited) |
|
|
(1) |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
149,392 |
|
|
$ |
247,577 |
|
Short-term investments |
|
|
199,750 |
|
|
|
188,550 |
|
Accounts receivable |
|
|
10,004 |
|
|
|
97 |
|
Prepaid expenses and other current assets |
|
|
7,531 |
|
|
|
9,251 |
|
Total current assets |
|
|
366,677 |
|
|
|
445,475 |
|
Property and equipment, net |
|
|
7,238 |
|
|
|
6,934 |
|
Intangible assets, net |
|
|
1,385 |
|
|
|
1,458 |
|
Goodwill |
|
|
949 |
|
|
|
949 |
|
Restricted cash |
|
|
917 |
|
|
|
917 |
|
Operating lease right-of-use |
|
|
26,743 |
|
|
|
— |
|
Other assets |
|
|
1,375 |
|
|
|
1,375 |
|
Total assets |
|
$ |
405,284 |
|
|
$ |
457,108 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
4,520 |
|
|
$ |
5,132 |
|
Accrued liabilities |
|
|
22,469 |
|
|
|
26,724 |
|
Income tax payable |
|
|
- |
|
|
|
13,339 |
|
Deferred revenue, current portion |
|
|
51,684 |
|
|
|
52,713 |
|
Total current liabilities |
|
|
78,673 |
|
|
|
97,908 |
|
Deferred revenue, net of current
portion |
|
|
197,826 |
|
|
|
225,267 |
|
Operating lease liabilities -
long term |
|
|
26,321 |
|
|
|
— |
|
Other long-term liabilities |
|
|
963 |
|
|
|
3,050 |
|
Total liabilities |
|
|
303,783 |
|
|
|
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 June 30, 2019 and December 31,
2018. |
|
|
— |
|
|
|
— |
|
Common stock, $0.00001 par value;
75,000,000 shares authorized; 45,403,838 and 45,083,209
shares issued and outstanding at June 30, 2019 and December 31,
2018, respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
459,367 |
|
|
|
445,956 |
|
Accumulated other comprehensive income (loss) |
|
|
209 |
|
|
|
(93 |
) |
Accumulated deficit |
|
|
(358,076 |
) |
|
|
(314,981 |
) |
Total stockholders' equity |
|
|
101,501 |
|
|
|
130,883 |
|
Total liabilities and
stockholders' equity |
|
$ |
405,284 |
|
|
$ |
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.
Investors: Christopher KeenanVP, Investor Relations and
Corporate Communicationsckeenan@cytomx.com650-383-0823
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