CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of
masked, conditionally activated biologics, today announced 2024
financial results and provided a business update.
“Throughout 2024 we continued to advance and
prioritize our multi-modality clinical pipeline with disciplined
capital allocation. Entering 2025, our top strategic priority is
the clinical development of our lead program, CX-2051, in advanced
colorectal cancer. CX-2051 is a masked EpCAM-targeting ADC armed
with a topoisomerase-1 payload, specifically designed to address
profound unmet need in CRC. EpCAM is highly expressed in more than
90 percent of colorectal cancers and we believe our PROBODY
platform offers a unique strategy to unlock the tremendous
potential of this previously undruggable target,” said Sean
McCarthy, D.Phil., chief executive officer and chairman of
CytomX.
Dr. McCarthy continued, “We are encouraged by
our progress to date in the first in human evaluation of CX-2051,
having successfully escalated to doses predicted to be in the
biologically active range. We believe CX-2051 is behaving as
designed, and we look forward to sharing preliminary clinical data
and future plans for CX-2051 in the coming months. We are
optimistic about the potential for CX-2051 in colorectal cancer,
and also in many other solid tumor types that express EpCAM and
where major unmet needs remain to be addressed.”
Pipeline Program Updates:
CX-2051 (EpCAM PROBODY Topo-1
ADC)
- CX-2051 has been
prioritized as Company’s lead clinical program with an initial
focus in advanced metastatic CRC. The Phase 1 study of CX-2051 was
initiated in April of 2024 and is focused on advanced metastatic
CRC, one of many tumor types where there is high expression of
EpCAM. CX-2051 contains a next generation topoisomerase-1 payload
(CAMP59) and a cleavable payload-antibody linker licensed from
AbbVie (formerly Immunogen).
- EpCAM (Epithelial
Cell Adhesion Molecule) is a highly expressed tumor antigen that
has been previously undruggable with systemically administered
agents due to expression on normal tissues. CX-2051 is designed to
open a therapeutic window for this high potential target and
deliver meaningful anti-cancer activity in solid tumors, including
CRC. CRC remains an area of high unmet medical need, especially in
the late-line setting, where outcomes from currently approved
standard of care remain extremely poor, with objective response
rates in the low-single digit percentages and approximately two to
four months of progression free survival1.
- The CX-2051 study
is currently enrolling patients with advanced CRC who have
generally received three or more prior lines of systemic therapy in
the metastatic setting. Enrolled patients are not being
pre-selected for EpCAM expression or for disease characteristics
such as KRAS mutational status or liver
metastases.
- In Phase 1 dose
escalation to date, CX-2051 has demonstrated a favorable
tolerability profile and doses predicted to be therapeutically
active, based on preclinical modeling, have been attained.
- The CX-2051 Phase 1
study is ongoing and is evaluating the seventh dose level.
- Initial Phase 1a
data in CRC are expected to be presented in the first half of
2025.
CX-801 (PROBODY Interferon-alpha
2b)
- Phase 1 dose
escalation continues with a focused early development strategy in
metastatic melanoma and with the goal of initiating combination
therapy with CX-801 and KEYTRUDA® in 2025.
- The Phase 1 study
is currently in the fourth monotherapy dose escalation cohort where
the dose of CX-801 exceeds the approved dose of the unmasked
peginterferon alfa-2b (SYLATRON™)2.
- Initial Phase 1a
translational and biomarker data in advanced melanoma is expected
in the second half of 2025.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA
CX-904 (EGFR-CD3 PROBODY
TCE)
- Based on CX-904
clinical observations to-date as well as CytomX pipeline
priorities, CytomX and Amgen have jointly decided to not further
develop CX-904.
Corporate and Financial:
-
Organization: In January 2025, CytomX announced a
reduction of organizational headcount by approximately 40 percent
in order to direct capital resources primarily to CX-2051 and
create additional flexibility in its cost structure. Headcount
reductions primarily impact areas supporting non-partnered early
research and general and administrative functions and are expected
to be completed by the end of the first quarter of 2025.
-
Financial: Cost reductions realized from the
January 2025 restructuring combined with focused clinical
development priorities are expected to extend cash runway into the
second quarter of 2026. CytomX ended 2024 with $100.6 million of
cash, cash equivalents and investments.
- Research
collaborations:
- New milestone
achieved in Astellas T-cell engager collaboration: In February
2025, Astellas advanced the second program to GLP toxicology
studies, triggering a $5 million milestone payment to CytomX.
- Multiple drug
discovery programs continue across our research collaborations with
a focus on T-cell engagers. CytomX has research collaborations with
Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna.
__________________________________1 Lonsurf®,
Fruzaqla®, Stivarga® package inserts.2 SYLATRON Prescribing
Information
Full Year 2024 Financial
Results:
Cash, cash equivalents and investments totaled
$100.6 million as of December 31, 2024, compared to $174.5 million
as of December 31, 2023.
Total revenue was $138.1 million for the year
ended December 31, 2024, compared to $101.2 million in 2023. The
increase in revenue was driven primarily by a higher percentage of
completion for research programs in the Bristol Myers Squibb
collaboration as well as the collaborations with Moderna, Astellas,
and Regeneron.
In 2024, CytomX remained focused on controlling
costs and efficiently progressing its pipeline programs. Total
operating expense in 2024 was $113.1 million compared to $107.7
million in 2023, an increase of $5.4 million. The increase in
operating expenses was primarily due to a $5.0 million milestone
payment to AbbVie (formerly ImmunoGen) as a result of dosing the
first patient for CX-2051 in Phase 1 based upon the ImmunoGen 2019
License Agreement.
Research and development expenses increased by
$5.7 million during the year ended December 31, 2024, to $83.4
million compared to $77.7 million in 2023. The $5.0 million
milestone payment to AbbVie for dosing of the first patient in the
CX-2051 Phase 1 study was recorded in 2024 as a research and
development expense and was the primary driver of increased
research and development spend in 2024 compared to 2023.
General and administrative expenses were essentially flat in
2024 compared to 2023, decreasing by $0.3 million to $29.7 million
for the year ended December 31, 2024.
About CytomX
TherapeuticsCytomX is a clinical-stage, oncology-focused
biopharmaceutical company focused on developing novel conditionally
activated, masked biologics designed to be localized to the tumor
microenvironment. By pioneering a novel pipeline of localized
biologics, powered by its PROBODY® therapeutic platform, CytomX’s
vision is to create safer, more effective therapies for the
treatment of cancer. CytomX’s robust and differentiated pipeline
comprises therapeutic candidates across multiple treatment
modalities including antibody-drug conjugates (“ADCs”), T-cell
engagers, and immune modulators such as cytokines. CytomX’s
clinical-stage pipeline includes CX-2051, CX-904 and CX-801.
CX-2051 is a masked, conditionally activated ADC directed toward
epithelial cell adhesion molecule (EpCAM), armed with a
topoisomerase-1 inhibitor payload. CX-2051 has potential
applicability across multiple EpCAM-expressing epithelial cancers,
including CRC, and was discovered in collaboration with ImmunoGen,
now part of AbbVie. CX-904 is a masked, conditionally activated
T-cell-engaging bispecific antibody targeting the epidermal growth
factor receptor (EGFR) on tumor cells and the CD3 receptor on T
cells. CX-904 is partnered with Amgen in a global co-development
alliance. CX-801 is a masked interferon alpha-2b PROBODY® cytokine
with broad potential applicability in traditionally immuno-oncology
sensitive as well as insensitive (cold) tumors. CytomX has
established strategic collaborations with multiple leaders in
oncology, including Amgen, Astellas, Bristol Myers Squibb,
Regeneron and Moderna. For more information about CytomX and how it
is working to make conditionally activated treatments the new
standard-of-care in the fight against cancer,
visit www.cytomx.com and follow us
on LinkedIn and X
(formerly 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, including those related to
the future potential of partnerships or collaboration agreements
and projected cash runway. 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, including
CX-2051 and CX-801, the potential benefits or applications of
CytomX’s PROBODY® therapeutic platform, CytomX’s or its
collaborative partners’ ability to develop and advance product
candidates into and successfully complete clinical trials,
including the ongoing and planned clinical trials of CX-2051 and
CX-801 and the timing of initial and ongoing data availability for
our clinical trials, including CX-2051, CX-904 and CX-801, and
other development milestones. Risks and uncertainties that
contribute to the uncertain nature of the forward-looking
statements include: the unproven nature of CytomX’s novel PROBODY®
therapeutic technology; uncertainties around the Company’s ability
to raise sufficient funds to carry out its planned research and
development; 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 possibility that
the results of preclinical research and early clinical trials,
including initial CX-2051 and CX-801 results, may not be predictive
of future results; the possibility that CytomX’s clinical trials
will not be successful; the possibility that current preclinical
research may not result in additional product candidates; CytomX’s
dependence on the success of CX-2051 and CX-801; CytomX’s reliance
on third parties for the manufacture of the Company’s product
candidates; possible regulatory developments in the United States
and foreign countries; and the risk that we may incur higher costs
than expected for research and development or unexpected costs and
expenses or may not obtain expected savings from our announced
restructuring. 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-K
filed with the SEC on March 6, 2025. 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, Inc. All other trademarks are the properties of their
respective owners.
Company Contact:Chris OgdenSVP,
Chief Financial Officercogden@cytomx.com
Investor Contact:Precision AQ
(formerly Stern Investor Relations)Stephanie
AscherStephanie.Ascher@precisionaq.com
Media Contact:Redhouse
CommunicationsTeri Dahlmanteri@redhousecomms.com
CYTOMX THERAPEUTICS, INC.STATEMENTS OF
OPERATIONS AND COMPREHENSIVE INCOME (LOSS)(in
thousands, except share and per share data) |
|
|
Year Ended December 31, |
|
|
2024 |
|
|
|
2023 |
|
Revenues |
$ |
138,103 |
|
|
$ |
101,214 |
|
Operating expenses: |
|
|
|
Research and development |
|
83,382 |
|
|
|
77,680 |
|
General and administrative |
|
29,726 |
|
|
|
30,018 |
|
Total operating expenses |
|
113,108 |
|
|
|
107,698 |
|
Income (loss) from
operations |
|
24,995 |
|
|
|
(6,484 |
) |
Interest income |
|
7,136 |
|
|
|
9,837 |
|
Other income (expense), net |
|
(38 |
) |
|
|
(30 |
) |
Income before income taxes |
|
32,093 |
|
|
|
3,323 |
|
Provision for income taxes |
|
224 |
|
|
|
3,892 |
|
Net income (loss) |
|
31,869 |
|
|
|
(569 |
) |
Other comprehensive income
(loss): |
|
|
|
Unrealized gain (loss) on available-for-sale investments, net of
tax |
|
(68 |
) |
|
|
85 |
|
Total comprehensive income
(loss) |
$ |
31,801 |
|
|
$ |
(484 |
) |
Net income (loss) per share: |
|
|
|
Basic |
$ |
0.38 |
|
|
$ |
(0.01 |
) |
Diluted |
$ |
0.38 |
|
|
$ |
(0.01 |
) |
Shares used to compute net income
(loss) per share |
|
|
|
Basic |
|
84,439,303 |
|
|
|
73,808,237 |
|
Diluted |
|
84,745,116 |
|
|
|
73,808,237 |
|
CYTOMX THERAPEUTICS, INC.BALANCE
SHEETS(in thousands) |
|
|
December 31, |
|
December 31, |
|
|
2024 |
|
|
|
2023 |
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
38,052 |
|
|
$ |
17,171 |
|
Short-term investments |
|
62,571 |
|
|
|
157,338 |
|
Accounts receivable |
|
3,103 |
|
|
|
3,432 |
|
Prepaid expenses and other current assets |
|
3,579 |
|
|
|
4,995 |
|
Total current assets |
|
107,305 |
|
|
|
182,936 |
|
Property and equipment, net |
|
2,467 |
|
|
|
3,958 |
|
Intangible assets, net |
|
583 |
|
|
|
729 |
|
Goodwill |
|
949 |
|
|
|
949 |
|
Restricted cash |
|
1,027 |
|
|
|
917 |
|
Operating lease right-of-use
asset |
|
8,136 |
|
|
|
12,220 |
|
Other assets |
|
66 |
|
|
|
83 |
|
Total assets |
$ |
120,533 |
|
|
$ |
201,792 |
|
Liabilities and
Stockholders' Deficit |
|
|
|
Current liabilities: |
|
|
|
Accounts payable |
$ |
1,088 |
|
|
$ |
1,458 |
|
Accrued liabilities |
|
12,338 |
|
|
|
17,599 |
|
Operating lease liabilities - short term |
|
5,145 |
|
|
|
4,589 |
|
Deferred revenues, current portion |
|
67,201 |
|
|
|
132,267 |
|
Total current liabilities |
|
85,772 |
|
|
|
155,913 |
|
Deferred revenue, net of current
portion |
|
26,862 |
|
|
|
80,048 |
|
Operating lease liabilities -
long term |
|
4,240 |
|
|
|
9,385 |
|
Other long-term liabilities |
|
4,115 |
|
|
|
3,893 |
|
Total liabilities |
|
120,989 |
|
|
|
249,239 |
|
Commitments and
contingencies |
|
|
|
Stockholders' deficit |
|
|
|
Convertible preferred stock |
|
— |
|
|
|
— |
|
Common stock |
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
691,095 |
|
|
|
675,905 |
|
Accumulated other comprehensive income |
|
27 |
|
|
|
95 |
|
Accumulated deficit |
|
(691,579 |
) |
|
|
(723,448 |
) |
Total stockholders' deficit |
|
(456 |
) |
|
|
(47,447 |
) |
Total liabilities and
stockholders' deficit |
$ |
120,533 |
|
|
$ |
201,792 |
|
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