CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of
masked, conditionally activated biologics, today announced first
quarter 2025 financial results and provided a business update.
“Our positive interim clinical results announced
today for CX-2051 in advanced colorectal cancer are highly
encouraging and provide a significant opportunity for CytomX. As an
EpCAM-directed ADC, CX-2051 was intentionally designed to address
the high unmet need in CRC. CX-2051 remains the Company’s top
strategic priority and is positioned to rapidly advance towards
later stage development. Just one year into the clinic, CX-2051
dose expansions are already in progress with a goal to initiate a
Phase 2 study in advanced CRC in the first half of 2026. This
excellent progress underscores the intense focus of the CytomX team
on diligent execution for the benefit of the patients we serve,”
said Sean McCarthy, D.Phil., chief executive officer and chairman
of CytomX.
Pipeline Program Updates:
CX-2051 (EpCAM PROBODY Topo-1
ADC)
- Announced positive interim data
from ongoing Phase 1 dose escalation study of EpCAM Antibody Drug
Conjugate (CX-2051) candidate in patients with advanced colorectal
cancer (CRC).
- Initiated CX-2051 dose expansions
at the 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg doses, administered every
three weeks (Q3W).
- Phase 1 data update in advanced CRC
in at least 70 patients is expected to be presented by Q1
2026.
- Planning Phase 2 study initiation
in 1H 2026
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™)1.
- 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
Corporate and Financial:
-
Financial:
- Focused clinical
development priorities and cost reductions implemented in Q1 2025
have extended the Company’s cash runway into the second quarter of
2026. CytomX ended the first quarter of 2025 with $79.9 million of
cash, cash equivalents and investments.
- Research
collaborations:
- Milestone achieved
in Astellas T-cell engager collaboration: In February 2025,
Astellas advanced the second program to GLP toxicology studies,
triggering a $5.0 million milestone payment to CytomX.
- Presented
preclinical data for mRNA encoded masked IL-12 molecule in
collaboration with Moderna at AACR Annual Meeting showing potent
anti-tumor activity with significantly enhanced tolerability vs.
unmasked IL-12 molecule.
- 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.
First Quarter 2025 Financial
Results:
Cash, cash equivalents and investments totaled
$79.9 million as of March 31, 2025, compared to $100.6 million as
of December 31, 2024.
Total revenue was $50.9 million for the quarter
ended March 31, 2025, compared to $41.5 million for the quarter
ended March 31, 2024. The increase in revenue was driven primarily
by a higher percentage of completion for research programs in the
Bristol Myers Squibb collaboration and the acceleration of revenue
recognition in the Amgen collaboration due to the decision to not
further develop the CX-904 program, partially offset by lower
Astellas milestones and Moderna revenue.
Total operating expense in the first quarter of
2025 was $28.3 million compared to $29.8 million in the first
quarter of 2024, a decrease of $1.5 million. Operating expenses in
the first quarter of 2025 included $2.9 million of one-time
expenses related to the Company’s January 2025 restructuring.
Research and development expenses were $18.9
million for the three months ended March 31, 2025, a decrease of
$3.2 million compared to the corresponding period of 2024. Reduced
research and development expenses were primarily due to reduced
pre-clinical activities in wholly owned and partnered programs and
decreased manufacturing activities for CX-801, partially offset by
increased clinical trial activities related to CX-2051 and CX-801,
and $1.8 million of restructuring expenses.
General and administrative expenses were $9.4
million for the three months ended March 31, 2025, an increase of
$1.7 million compared to the corresponding period of 2024. The
increase in general and administrative expenses was primarily
driven by $1.1 million of restructuring expenses as well as other
personnel-related expenses.
____________________________1 SYLATRON Prescribing
Information
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 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. 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
CX-2051. 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 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 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, including China and the
European Union; 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-Q
filed with the SEC on May 12, 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.CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE
INCOME(in thousands, except share and per share
data)(Unaudited) |
|
|
Three Months Ended |
|
|
March 31, |
|
|
2025 |
|
|
2024 |
|
Revenues |
$ |
50,917 |
|
|
$ |
41,463 |
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
18,868 |
|
|
|
22,052 |
|
General and administrative |
|
9,428 |
|
|
|
7,754 |
|
Total operating expenses |
|
28,296 |
|
|
|
29,806 |
|
Income
from operations |
|
22,621 |
|
|
|
11,657 |
|
Interest income |
|
955 |
|
|
|
2,194 |
|
Other (expense) income, net |
|
11 |
|
|
|
(11 |
) |
Income
before income taxes |
|
23,587 |
|
|
|
13,840 |
|
Provision for income taxes |
|
62 |
|
|
|
49 |
|
Net
Income |
|
23,525 |
|
|
|
13,791 |
|
Other
comprehensive income (loss): |
|
|
|
|
|
Unrealized loss on investments, net of tax |
|
(28 |
) |
|
|
(105 |
) |
Total
comprehensive income |
$ |
23,497 |
|
|
$ |
13,686 |
|
|
|
|
|
|
|
Net
income per share: |
|
|
|
|
|
Basic |
$ |
0.27 |
|
|
$ |
0.17 |
|
Diluted |
$ |
0.27 |
|
|
$ |
0.17 |
|
Shares
used to compute net income per share |
|
|
|
|
|
Basic |
|
87,121,502 |
|
|
|
82,029,466 |
|
Diluted |
|
87,150,666 |
|
|
|
82,630,020 |
|
CYTOMX THERAPEUTICS, INC.CONDENSED BALANCE
SHEETS(in thousands) |
|
|
March 31, |
|
|
December 31, |
|
2025 |
|
|
2024 |
|
|
(unaudited) |
|
|
(1 |
) |
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
$ |
47,604 |
|
|
$ |
38,052 |
|
Short-term investments |
|
32,282 |
|
|
|
62,571 |
|
Accounts receivable |
|
1,956 |
|
|
|
3,103 |
|
Prepaid expenses and other current assets |
|
4,786 |
|
|
|
3,579 |
|
Total current assets |
|
86,628 |
|
|
|
107,305 |
|
Property and equipment,
net |
|
2,229 |
|
|
|
2,467 |
|
Intangible assets, net |
|
547 |
|
|
|
583 |
|
Goodwill |
|
949 |
|
|
|
949 |
|
Restricted cash |
|
1,028 |
|
|
|
1,027 |
|
Operating lease right-of-use
asset |
|
7,055 |
|
|
|
8,136 |
|
Other assets |
|
61 |
|
|
|
66 |
|
Total assets |
$ |
98,497 |
|
|
$ |
120,533 |
|
Liabilities and
Stockholders' Equity (Deficit) |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable |
$ |
276 |
|
|
$ |
1,088 |
|
Accrued liabilities |
|
11,406 |
|
|
|
12,338 |
|
Operating lease liabilities - short term |
|
5,293 |
|
|
|
5,145 |
|
Deferred revenue, current portion |
|
33,226 |
|
|
|
67,201 |
|
Total current liabilities |
|
50,201 |
|
|
|
85,772 |
|
Deferred revenue, net of
current portion |
|
16,214 |
|
|
|
26,862 |
|
Operating lease liabilities -
long term |
|
2,856 |
|
|
|
4,240 |
|
Other long term
liabilities |
|
4,177 |
|
|
|
4,115 |
|
Total liabilities |
|
73,448 |
|
|
|
120,989 |
|
Commitments and
contingencies |
|
|
|
|
Stockholders' equity
(deficit): |
|
|
|
|
Convertible preferred stock |
|
— |
|
|
|
— |
|
Common stock |
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
693,103 |
|
|
|
691,095 |
|
Accumulated other comprehensive (loss) income |
|
(1 |
) |
|
|
27 |
|
Accumulated deficit |
|
(668,054 |
) |
|
|
(691,579 |
) |
Total stockholders' equity
(deficit) |
|
25,049 |
|
|
|
(456 |
) |
Total liabilities and
stockholders' equity (deficit) |
$ |
98,497 |
|
|
$ |
120,533 |
|
__________________(1) The condensed balance
sheet as of December 31, 2024 was derived from the audited
financial statements included in the Company's Annual Report on
Form 10-K for the year ended December 31, 2024.
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