CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of
conditionally activated oncology therapeutics, today reported first
quarter 2022 financial results and provided a business update.
“The CytomX team continued to execute across our
portfolio during the first quarter of 2022, including significant
progress with patient enrollment in our most advanced clinical
studies. Initial data readouts for both Arms A and B for
praluzatamab ravtansine and a data update for CX-2029 remain on
track for the second half of this year. Beyond these important
milestones, we are also advancing many new experimental
therapeutics, including our conditionally activated version of
interferon alpha-2b, which was detailed in a presentation at the
recent American Association for Cancer Research Annual Meeting. The
breadth of our clinical and preclinical pipeline continues to
demonstrate the multi-modality potential of our technology platform
to deliver important new treatments for cancer,” said Sean
McCarthy, D.Phil., chief executive officer and chairman at CytomX
Therapeutics.
First Quarter Business Highlights and
Recent Developments
- Praluzatamab
ravtansine – Praluzatamab ravtansine is a CD166-directed
conditionally activated antibody-drug conjugate (ADC) wholly-owned
by CytomX. The three-arm Phase 2 study is evaluating praluzatamab
ravtansine as monotherapy in patients with hormone
receptor-positive, human epidermal growth factor receptor
2-non-amplified breast cancer (Arm A) and in patients with
triple-negative breast cancer (TNBC, Arm B), and in combination
with pacmilimab, our PD-L1 directed Probody therapeutic, in
patients with TNBC (Arm C). Enrollment to Arm A is complete.
- CX-2029 – CX-2029
is a CD71-directed conditionally activated ADC being co-developed
by CytomX and AbbVie. In addition to head and neck squamous cell
carcinoma, the Phase 2 expansion study has now also completed
patient enrollment in the squamous non-small cell lung cancer
cohort. The study remained open for enrollment in the esophageal
and gastro-esophageal junction cancers cohort, and the diffuse
large B-cell lymphoma cohort.
- CX-904 – CX-904 is
a conditionally activated T-cell-engaging bispecific antibody
targeting the epidermal growth factor receptor (EGFR) on tumor
cells and the CD3 receptor on T cells, and is partnered with Amgen.
The investigational new drug application for a first-in-human Phase
1 study of CX-904 in patients with advanced solid tumors was
allowed to proceed by the U.S. Food and Drug Administration and
study start-up activities were initiated.
- Ipilimumab Probody
Program – BMS-986249 and BMS-986288 are Probody versions
of the anti-CTLA4 antibody, ipilimumab and non-fucosylated
ipilimumab, respectively. BMS-986249 is currently being evaluated
by CytomX’s collaboration partner, Bristol Myers Squibb, in a
randomized Phase 2 study in combination with nivolumab, the
anti-PD-1 antibody, versus ipilimumab plus nivolumab in patients
newly diagnosed with advanced melanoma. This novel combination is
also being studied in advanced hepatocellular carcinoma,
castration-resistant prostate cancer, and TNBC. Bristol Myers
Squibb also continued to evaluate BMS-986288, as monotherapy and in
combination with nivolumab, in a Phase 1 study in advanced solid
tumors.
- Preclinical
Programs – CytomX continued to work on broadening the
potential application of its multi-modality Probody platform to
other product candidates, including a broad initiative towards
enhancing the therapeutic window of cytokines. At the 2022 AACR
Annual Meeting, CytomX presented encouraging preclinical data that
highlighted a conditionally activated interferon alpha-2b
therapeutic candidate as a promising addition to current
immunotherapy regimens, potentially expanding benefit to patients
with typically unresponsive tumors.
Priorities for 2022
- Continue enrolling patients with
TNBC in Arms B and C in the Phase 2 study of praluzatamab
ravtansine and report initial data from Arms A and B in the second
half of 2022
- Continue advancing the expansion
phase of the Phase 2 study of CX-2029 in collaboration with our
partner AbbVie and provide a data update in the second half of
2022
- Advance the Phase 1 study of CX-904
in solid tumors
First Quarter 2022 Financial
ResultsCash, cash equivalents and investments totaled $263
million as of March 31, 2022, compared to $305 million as of
December 31, 2021.
Total revenue was $17.1 million for the three
months ended March 31, 2022 compared to $16.0 million for the
corresponding period in 2021. The increase in total revenue was
largely related to the CD71 collaboration with AbbVie.
Research and development expenses increased by
$8.2 million during the three months ended March 31, 2022 to $30.6
million compared to $22.4 million for the first quarter of 2021.
The increase was primarily driven by contract and service expenses
in manufacturing and development activities in support of our
pre-clinical and clinical portfolio.
General and administrative expenses increased by
$1.3 million during the first quarter of 2022 to $10.5 million
compared to $9.2 million in the same period in 2021. The increase
was mainly in personnel and professional expenses.
Conference Call & Webcast
InformationCytomX management will host a conference call
and a simultaneous webcast today at 5:00 p.m. ET (2:00 p.m. PT) to
discuss the financial results and provide a business update. To
join the conference call, please dial (877) 809-6037 (domestic) or
(615) 247-0221 (international) and reference the conference ID
5241057. A live webcast of the call can be accessed on the Events
and Presentations page of CytomX's website at
https://ir.cytomx.com/events-and-presentations. An archived replay
of the webcast will be available on the Company’s website until May
12, 2022.
About CytomX Therapeutics,
Inc.CytomX is a clinical-stage, oncology-focused
biopharmaceutical company dedicated to destroying cancer
differently. By pioneering a novel class of conditionally activated
biologics, powered by its Probody® technology platform, CytomX’s
goal is to transcend the limits of current cancer treatments by
successfully leveraging therapeutic targets that were once thought
to be inaccessible. CytomX’s robust and differentiated pipeline
includes the wholly-owned praluzatamab ravtansine (CX-2009), an
investigational conditionally activated antibody-drug conjugate
(ADC) directed toward CD166, and CX-2029, an investigational
conditionally activated ADC directed toward CD71 being developed in
collaboration with AbbVie. These two programs are currently being
evaluated in Phase 2 studies, targeting a variety of late-stage,
difficult-to-treat cancer types, including breast cancer for
praluzatamab ravtansine, and squamous non-small cell lung cancer,
and head and neck squamous cell carcinoma for CX-2029. CytomX’s
clinical pipeline also includes cancer immunotherapeutic candidates
against validated targets such as the CTLA-4-targeting Probody
therapeutics, BMS-986249 and BMS-986288, partnered with Bristol
Myers Squibb, and our wholly-owned conditionally activated
anti-PD-L1 antibody, pacmilimab (CX-072), as well as CX-904, a
conditionally activated T-cell-engaging bispecific antibody
targeting the epidermal growth factor receptor on tumor cells and
the CD3 receptor on T cells, which is partnered with Amgen. In
addition, CytomX has a diverse preclinical portfolio and strategic
collaborations with multiple leaders in oncology, including AbbVie,
Amgen, Astellas, and Bristol Myers Squibb. 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 Twitter.
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. 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
praluzatamab ravtansine (CX-2009), CX-2029, BMS-986249, BMS-986288,
pacmilimab, and CX-904, 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 praluzatamab ravtansine, CX-2029, BMS-986249, BMS-986288,
pacmilimab, and CX-904, and the timing of the commencement of
clinical trials, initial and ongoing data availability,
investigational new drug applications 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 Platform technology;
CytomX’s clinical trial product candidates, including CX-904, 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 preclinical research may not result in additional product
candidates; CytomX’s dependence on the success of praluzatamab
ravtansine, CX-2029, BMS-986249, BMS-986288, pacmilimab, and
CX-904; 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 Annual Report on Form 10-K filed with
the SEC on March 1, 2022. 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.
Investor Contact:Chau Cheng,
PhD MBAVP, Investor Relations & Corp.
Communicationsccheng@cytomx.comDirect: (650) 273-4999
Media Contact:Bret
CoonsDirector, Corporate Communicationsbcoons@cytomx.comDirect:
(650) 528 2929
|
CYTOMX THERAPEUTICS, INC.STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS(in thousands,
except share and per share data) |
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2022 |
|
|
2021 |
|
Revenues |
|
$ |
17,136 |
|
|
$ |
15,971 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
30,559 |
|
|
|
22,371 |
|
General and administrative |
|
|
10,543 |
|
|
|
9,227 |
|
Total operating expenses |
|
|
41,102 |
|
|
|
31,598 |
|
Loss from operations |
|
|
(23,966 |
) |
|
|
(15,627 |
) |
Interest income |
|
|
68 |
|
|
|
68 |
|
Other income, net |
|
|
13 |
|
|
|
5 |
|
Net loss |
|
|
(23,885 |
) |
|
|
(15,554 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
Unrealized gain (loss) on short-term investments, net of tax |
|
|
(677 |
) |
|
|
4 |
|
Comprehensive loss |
|
$ |
(24,562 |
) |
|
$ |
(15,550 |
) |
|
|
|
|
|
|
|
Net loss per share: |
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.37 |
) |
|
$ |
(0.26 |
) |
Shares used in computing basic and diluted net loss per share |
|
|
65,393,691 |
|
|
|
60,968,111 |
|
|
|
|
|
|
|
|
|
|
|
CYTOMX THERAPEUTICS, INC.BALANCE
SHEETS(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2022 |
|
|
2021 |
|
|
|
(unaudited) |
|
|
(1) |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
163,488 |
|
|
$ |
205,530 |
|
Short-term investments |
|
|
99,042 |
|
|
|
99,696 |
|
Accounts receivable |
|
|
1,016 |
|
|
|
790 |
|
Prepaid expenses and other current assets |
|
|
4,898 |
|
|
|
4,285 |
|
Total current assets |
|
|
268,444 |
|
|
|
310,301 |
|
Property and equipment, net |
|
|
6,093 |
|
|
|
5,960 |
|
Intangible assets, net |
|
|
984 |
|
|
|
1,021 |
|
Goodwill |
|
|
949 |
|
|
|
949 |
|
Restricted cash |
|
|
917 |
|
|
|
917 |
|
Operating lease right-of-use
asset |
|
|
18,536 |
|
|
|
19,362 |
|
Other assets |
|
|
902 |
|
|
|
901 |
|
Total assets |
|
$ |
296,825 |
|
|
$ |
339,411 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,721 |
|
|
$ |
2,818 |
|
Accrued liabilities |
|
|
31,032 |
|
|
|
34,236 |
|
Deferred revenue, current portion |
|
|
70,013 |
|
|
|
69,262 |
|
Total current liabilities |
|
|
102,766 |
|
|
|
106,316 |
|
Deferred revenue, net of current
portion |
|
|
108,788 |
|
|
|
125,660 |
|
Operating lease liabilities -
long term |
|
|
17,077 |
|
|
|
18,056 |
|
Total liabilities |
|
|
228,631 |
|
|
|
250,032 |
|
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, 2022 and December 31,
2021. |
|
|
— |
|
|
|
— |
|
Common stock, $0.00001 par value;
150,000,000 shares authorized and 65,398,355 and 65,392,758 shares
issued and outstanding at March 31, 2022 and December 31, 2021,
respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
626,721 |
|
|
|
623,344 |
|
Accumulated other comprehensive loss |
|
|
(919 |
) |
|
|
(242 |
) |
Accumulated deficit |
|
|
(557,609 |
) |
|
|
(533,724 |
) |
Total stockholders' equity |
|
|
68,194 |
|
|
|
89,379 |
|
Total liabilities and
stockholders' equity |
|
$ |
296,825 |
|
|
$ |
339,411 |
|
__________________(1) The condensed balance sheet as of December
31, 2021 was derived from the audited financial statements included
in the Company's Annual Report on Form 10-K for the year ended
December 31, 2021.
CytomX Therapeutics (NASDAQ:CTMX)
Historical Stock Chart
Von Apr 2024 bis Mai 2024
CytomX Therapeutics (NASDAQ:CTMX)
Historical Stock Chart
Von Mai 2023 bis Mai 2024