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 2020
financial results and provides a business update.
“The first quarter of 2020 presented unique challenges as we
navigated the early stages of the COVID-19 pandemic, but through a
strategic pipeline reprioritization and excellent progress with new
and existing research and development partnerships, we entered the
second quarter well positioned for the remainder of the year and
beyond,” said Sean McCarthy, D.Phil., president, chief executive
officer and chairman of CytomX Therapeutics. “Our continued
achievements reflect our long-term strategic vision for CytomX and
include the progression of multiple wholly-owned and partnered
programs into or towards Phase 2 clinical trials alongside a major
new collaboration with Astellas that further validates our Probody
platform. Our intensified focus on the application of Probody
technology to undruggable targets is aimed at making the biggest
difference for patients with cancer.”
First Quarter Business Highlights and Recent
Developments
COVID 19 Pandemic and Business Continuity
CytomX is committed to ensuring the health, safety and well-being
of its clinical study participants, staff at our study sites and
our employees. CytomX continues to closely monitor the COVID-19
pandemic situation and is following local, state, and federal
guidelines, including, with respect to the conduct of our worldwide
clinical trials, emerging Health Authority guidance and IRB/Ethics
Committee recommendations.
STRATEGIC REPRIORITIZATION OF WHOLLY OWNED CLINICAL
PIPELINE INCREASES FOCUS ON UNDRUGGABLE TARGETS AND FIRST-IN-CLASS
DRUG DEVELOPMENT
PROCLAIM-CX-2009-001
- CytomX made the decision in March 2020 to temporarily pause new
patient enrollment and new site activation in the
PROCLAIM-CX-2009-001 study evaluating the CD166-targeting Probody
drug conjugate CX-2009. This study includes the Phase 2 expansion
study evaluating CX-2009 as monotherapy in patients with hormone
receptor (ER, PR) positive, HER2 negative breast cancer. This
decision followed the assessment of the evolving COVID-19 pandemic,
and the emerging challenges for clinical trial execution within our
studies and across the industry. CytomX intends to resume the
CX-2009 clinical program as soon as practicable.
PROCLAIM-CX-072-002
- CytomX also made the strategic decision in March 2020 to
terminate the PROCLAIM-CX-072-002 study evaluating the anti-PD-L1
Probody CX-072 in combination with ipilimumab in melanoma. This
follows a re-evaluation of the evolving clinical, competitive, and
commercial landscapes in immuno-oncology, taken together with
impact of the COVID-19 pandemic.
- This strategic decision allows CytomX to focus its resources on
its potential first-in-class assets, CX-2009 and CX-2029, to the
future evaluation of a combination of CX-072 and CX-2009, and to
the generation of additional clinical candidates for advancement to
IND filing and clinical trials.
SIGNIFICANT PROGRESS WITHIN NEW AND EXISTING STRATEGIC
COLLABORATIONS
Astellas Collaboration – Newly Formed Alliance Expands
Research and Development in the Field of T-Cell Engaging
Bispecifics
- CytomX announced a strategic collaboration with Astellas Pharma
Inc. focusing on the discovery, development, and
commercialization of novel CD3 targeting T-cell engaging bispecific
antibodies for the treatment of cancer. Astellas paid CytomX an
upfront cash payment of $80 million, that was received in April,
with CytomX eligible to receive future preclinical, clinical, and
commercial milestones of over $1.6 billion. CytomX is also eligible
to receive tiered royalties on global net sales that range from
high-single digits to mid-teens.
AbbVie Collaboration - Phase 2 Expansion Stage Study
Advances CX-2029, A First-in-Class Anti-CD71 Probody Drug
Conjugate
- CytomX announced a $40 million milestone payment, to be
received by CytomX from AbbVie in the second quarter, through the
achievement of pre-specified criteria for the dose escalation phase
of the ongoing Phase 1/2 clinical trial, PROCLAIM-CX-2029. CytomX
and AbbVie are finalizing plans for the advancement of CX-2029 to
Phase 2 expansion cohorts in select tumor types. Additional
information is available at ClinicalTrials.gov using the Identifier
NCT003543813.
Bristol Myers Squibb Collaboration - Advancement of
ipilimumab Probody into Randomized Phase 2 Study
- Bristol Myers Squibb initiated a Phase 2 randomized cohort
expansion in its ongoing first-in-human Phase 1/2a trial of the
anti-CTLA-4 Probody BMS-986249, a Probody version of the
anti-CTLA-4 antibody Yervoy® (ipilimumab), in combination with
Opdivo® (nivolumab) in patients with metastatic melanoma. This
advancement triggered a milestone payment of $10 million that was
received by CytomX in April. Additional information is available at
ClinicalTrials.gov using the Identifier NCT03369223.
Amgen Collaboration - Advancement of Lead T-Cell
Bispecific Candidate into IND Enabling Studies
- CytomX, in partnership with Amgen, has recently advanced
CX-904, a lead T-cell engaging bispecific Probody candidate against
Epidermal Growth Factor Receptor (EGFR) and CD3, into IND-enabling
studies. CytomX is responsible for the IND filing, targeted for
late 2021, and for early clinical development
ASCO 2020 PRESENTATIONS TO HIGHLIGHT MULTIPLE PROBODY
CLINICAL-STAGE PROGRAMS CytomX and its partners announced
presentations at the American Society of Clinical Oncology’s (ASCO)
ASCO20 Virtual Scientific Program
- CytomX and its partner AbbVie will present data from Phase 1
dose escalation study of the PROCLAIM-CX-2029 Phase 1/2 study of
the anti CD71 Probody CX-2029
- Bristol Myers Squibb will present data from the Phase 1 dose
escalation study of the Phase 1/2a trial of the anti-CTLA-4 Probody
BMS-986249
- CytomX will present updated data from the Phase 1 dose
escalation and dose ranging studies of the PROCLAIM-CX-2009 Phase
1/2 study of the anti CD166 Probody CX-2009
- CytomX will present updated data from the Phase 1 dose
escalation study, monotherapy expansion studies and combination
with ipilimumab studies of PROCLAIM-CX-072 Phase 1/2 study of the
anti PD-L1 Probody CX-072
Executive Appointments
- Announced the appointments of Carlos Campoy, as senior vice
president and chief financial officer and Alison Hannah, M.D., as
senior vice president and chief medical officer.
First Quarter 2020 Financial Results
Cash, cash equivalents and short-term investments totaled $247.9
million as of March 31, 2020, compared to $296.1 million as of
December 31, 2019.
Revenue was $49.6 million for the three months ended March 31,
2020, compared to $29.5 million for the three months ended March
31, 2019. The net increase in revenue of $20.1 million was
primarily due to an increase in revenue of $26.6 million relating
to the partial revenue recognition of the $40 million milestone
earned from AbbVie associated with the PROCLAIM-CX-2029 project in
the first quarter of 2020, an increase of $10 million relating to
the milestone earned from Bristol Myers Squibb associated with the
initiation of the Phase 2 randomized cohort expansion in the first
quarter of 2020, partially offset by a decrease in revenue of $17.4
million relating to the accelerated recognition of revenue in the
first quarter of 2019 due to reprioritization within our alliance
with Bristol Myers Squibb.
Research and development expenses increased by $6.4 million
during the three months ended March 31, 2020 compared to the
corresponding period in 2019. The increase was largely
attributed to $9.1 million of sublicense fees paid to the
University of California, Santa Barbara associated with the
milestones and upfront payments earned in the first quarter of 2020
and a $3.0 million license fee to ImmunoGen associated with the
first dosing of a patient in the CX-2009 Phase 2 clinical trial
during the first quarter of 2020. These increases were
partially offset by a $5.0 million decrease associated with the
acquisition of technical know-how related to drug conjugate
linker-toxin and CD3-based bispecific technologies during the first
quarter of 2019.
General and administrative expenses were essentially flat during
the three months ended March 31, 2020 compared to the corresponding
period in 2019.
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 6282129. An archive of the
webcast will be available on the CytomX website from May 7, 2020,
until May 14, 2020.
About CytomX Therapeutics CytomX is a
clinical-stage, oncology-focused biopharmaceutical company with a
vision of transforming lives with safer, more effective therapies.
We are developing a novel class of investigational antibody
therapeutics, based on our Probody® technology platform, for
the treatment of cancer. Probody therapeutics are designed to
remain inactive until they are activated by proteases in the tumor
microenvironment. As a result, Probody therapeutics are intended to
bind selectively to tumors and decrease binding to healthy tissue,
to minimize toxicity and potentially create safer, more effective
therapies. As leaders in the field, our innovative technology is
designed to turn previously undruggable targets into druggable
targets and to enable more effective combination therapies. CytomX
and its partners, comprised of leading biotechnology and
pharmaceutical companies, have developed a robust pipeline of
potential first-in-class therapeutic candidates against novel,
difficult to drug targets and potential best-in-class
immunotherapeutic candidates against clinically validated targets.
The CytomX clinical stage pipeline includes first-in-class product
candidates against previously undruggable 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. The
CytomX clinical stage pipeline also includes cancer
immunotherapeutic candidates against validated targets such as the
CTLA-4-targeting Probody therapeutics, and BMS-986249 and
BMS-986288, partnered with Bristol Myers Squibb. CytomX has
strategic drug discovery and development collaborations with
AbbVie, Amgen, Astellas and Bristol Myers Squibb. For additional
information about CytomX Therapeutics,
visit www.cytomx.com and follow us
on LinkedIn and 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, safety and efficacy or progress of CytomX’s
or any of its collaborative partners’ product candidates , 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 and planned clinical trials of CX-2009 and
CX-2029, and the expected timing of the announcement of clinical
trial data. 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;
CytomX’s clinical trial product candidates 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, including the risk that the COVID-19 worldwide
pandemic may continue to negatively impact the business, research
and clinical operations of CytomX or its partners, including the
development of preclinical drug candidates due to delays in and
disruption of research activities, and the development of clinical
drug candidates, due to delays in or disruption of
clinical trials, including impacts on the enrollment of patients in
clinical trials or other clinical trial disruptions; 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; the possibility that
current pre-clinical research may not result in additional product
candidates; CytomX’s dependence on the success of CX-2009, CX-2029,
BMS-986249 and BMS-986288; 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 7, 2020. 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.
PROBODY is a U.S. registered trademark of CytomX Therapeutics.
Yervoy and Opdivo are registered trademarks of Bristol Myers
Squibb.
CYTOMX THERAPEUTICS,
INC.CONDENSED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (LOSS)(in thousands, except
share and per share data)(unaudited)
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2020 |
|
|
2019 |
|
Revenues |
|
$ |
49,593 |
|
|
$ |
29,485 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
42,814 |
|
|
|
36,376 |
|
General and administrative |
|
|
9,572 |
|
|
|
9,674 |
|
Total operating expenses |
|
|
52,386 |
|
|
|
46,050 |
|
Loss from operations |
|
|
(2,793 |
) |
|
|
(16,565 |
) |
Interest income |
|
|
1,075 |
|
|
|
2,496 |
|
Other income (expense) |
|
|
12 |
|
|
|
(61 |
) |
Loss before income taxes |
|
|
(1,706 |
) |
|
|
(14,130 |
) |
Benefit from income taxes |
|
|
(13,911 |
) |
|
|
(6 |
) |
Net income (loss) |
|
$ |
12,205 |
|
|
$ |
(14,124 |
) |
Net income (loss) per share |
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.27 |
|
|
$ |
(0.31 |
) |
Diluted |
|
$ |
0.26 |
|
|
$ |
(0.31 |
) |
Shares used to compute net income
(loss) per share |
|
|
|
|
|
|
|
|
Basic |
|
|
45,723,955 |
|
|
|
45,122,456 |
|
Diluted |
|
|
47,044,774 |
|
|
|
45,122,456 |
|
Other comprehensive income: |
|
|
|
|
|
|
|
|
Unrealized gain on short-term investments, net of tax |
|
$ |
279 |
|
|
$ |
155 |
|
Impact of adoption of new accounting pronouncement |
|
|
— |
|
|
|
11 |
|
Comprehensive income (loss) |
|
$ |
12,484 |
|
|
$ |
(13,958 |
) |
|
|
|
|
|
|
|
|
|
CYTOMX THERAPEUTICS,
INC.CONDENSED BALANCE SHEETS(in
thousands, except share and per share data)
|
|
March 31, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
|
(unaudited) |
|
|
(1) |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
143,286 |
|
|
$ |
188,425 |
|
Short-term investments |
|
|
104,636 |
|
|
|
107,720 |
|
Accounts receivable |
|
|
130,010 |
|
|
|
13 |
|
Income tax receivable |
|
|
13,061 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
|
9,073 |
|
|
|
7,177 |
|
Total current assets |
|
|
400,066 |
|
|
|
303,335 |
|
Property and equipment, net |
|
|
7,393 |
|
|
|
7,372 |
|
Intangible assets, net |
|
|
1,276 |
|
|
|
1,312 |
|
Goodwill |
|
|
949 |
|
|
|
949 |
|
Restricted cash |
|
|
917 |
|
|
|
917 |
|
Operating lease right-of-use
asset |
|
|
24,682 |
|
|
|
25,382 |
|
Other assets |
|
|
1,379 |
|
|
|
2,015 |
|
Total assets |
|
$ |
436,662 |
|
|
$ |
341,282 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,782 |
|
|
$ |
4,158 |
|
Accrued liabilities |
|
|
28,353 |
|
|
|
30,051 |
|
Deferred revenue, current portion |
|
|
73,866 |
|
|
|
51,381 |
|
Total current liabilities |
|
|
106,001 |
|
|
|
85,590 |
|
Deferred revenue, net of current
portion |
|
|
236,789 |
|
|
|
178,858 |
|
Operating lease liabilities -
long term |
|
|
24,105 |
|
|
|
24,871 |
|
Other long-term liabilities |
|
|
— |
|
|
|
850 |
|
Total liabilities |
|
|
366,895 |
|
|
|
290,169 |
|
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, 2020 and December 31,
2019. |
|
|
— |
|
|
|
— |
|
Common stock, $0.00001 par value;
75,000,000 shares authorized; 45,918,616 and 45,523,088 shares
issued and outstanding at March 31, 2020 and December 31, 2019,
respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
474,455 |
|
|
|
468,285 |
|
Accumulated other comprehensive income |
|
|
336 |
|
|
|
57 |
|
Accumulated deficit |
|
|
(405,025 |
) |
|
|
(417,230 |
) |
Total stockholders' equity |
|
|
69,767 |
|
|
|
51,113 |
|
Total liabilities and
stockholders' equity |
|
$ |
436,662 |
|
|
$ |
341,282 |
|
|
|
|
|
|
|
|
|
|
(1) The condensed balance sheet as of December 31, 2019 was
derived from the audited financial statements included in the
Company's Annual Report on Form 10-K for the year ended December
31, 2019.
Investor and Media Contact: Christopher KeenanVP, Investor
Relations and Corporate
Communicationsckeenan@cytomx.com650-383-0823
CytomX Therapeutics (NASDAQ:CTMX)
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