CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage
oncology-focused biopharmaceutical company pioneering a novel class
of investigational conditionally activated antibody therapeutics
based on its Probody® technology platform, today reported fourth
quarter and full year 2020 financial results and provided a
business update.
“2020 was a highly productive year for CytomX in
which we saw our clinical-stage pipeline advance to now encompass
Phase 2 evaluations of four Probody therapeutics across nine cancer
types, all while contending with the challenges posed by the
COVID-19 pandemic. We have demonstrated that our Probody masking
technology has the potential to widen or create a therapeutic
window for first-in-class and validated oncology targets and we
continue to execute on our strategic plan of delivering on the
promise of our technology platform for transforming the lives of
people with cancer,” said Sean McCarthy, D.Phil., president, chief
executive officer and chairman of CytomX Therapeutics. “Our
leadership in the research, discovery and development of
conditionally activated antibody therapeutic candidates positions
us well for future growth as we now drive to important Phase 2
datasets for praluzatamab ravtansine (CX-2009) and CX-2029,
directed against the targets CD166 and CD71, respectively, which
have historically been considered to be undruggable. We are also
pleased with the ongoing progress within our strategic partnerships
including recent commitments from our foundational partner, Bristol
Myers Squibb, to expand the evaluation of anti-CTLA-4 antibody,
BMS-986249, into additional tumor types,” continued Dr.
McCarthy.
Business Highlights and Recent
Developments
- Presented at the 2020 San Antonio
Breast Cancer Symposium updated data from the Phase 1 study of the
anti-CD166 conditionally activated antibody-drug conjugate (ADC),
praluzatamab ravtansine (CX-2009), in patients with human epidermal
growth factor receptor 2 (HER2)-non-amplified breast cancer and
translational data demonstrating measurable levels of activated
praluzatamab ravtansine in tumor tissue, which supported the launch
in December 2020 of a three-arm Phase 2 study. Arms A and B will
study praluzatamab ravtansine as a single agent in patients with
hormone receptor-positive (HR+), HER2-non-amplified breast cancer
and triple-negative breast cancer (TNBC), respectively. Arm C will
examine the combination of praluzatamab ravtansine and pacmilimab
(CX-072), the Company’s proprietary conditionally activated
anti-PD-L1 therapeutic candidate, in TNBC.
- Continued patient enrollment in the
Phase 2 expansion study of CX-2029, in partnership with AbbVie,
evaluating the anti-CD71 conditionally activated ADC as a single
agent in four cohorts: squamous non-small cell lung cancer, head
and neck squamous cell carcinoma, esophageal and gastro-esophageal
junction cancers, and diffuse large B-cell lymphoma.
- Our partner, Bristol Myers Squibb,
continued enrollment in its ongoing, randomized Phase 1/2a study of
BMS-986249 in patients with previously-untreated unresectable stage
III-IV melanoma and expanded the scope of the Part 2b evaluation to
include three new cohorts, enrolling patients with advanced
hepatocellular carcinoma, metastatic castration-resistant prostate
cancer, and unresectable locally advanced or metastatic TNBC. BMS
also continued enrollment into a Phase 1 study of a second
anti-CTLA-4 Probody, BMS-986288.
- Advancement of our third
conditionally activated ADC, CX-2043, into investigational new drug
(IND)-enabling studies. CX-2043 is directed against the epithelial
cell adhesion molecule (EpCAM/Trop-1), a high potential target with
elevated expression on a wide variety of tumor types.
- Continued IND-enabling studies for
CX-904, our most advanced program in the new and promising modality
of T-cell engaging bispecific antibodies. CX-904, partnered with
Amgen, targets the epidermal growth factor receptor on tumor cells
and the CD3 receptor on T cells.
- Continued drug discovery activities
for conditionally activated T-cell engaging bispecific antibodies
as part of our strategic collaboration with Astellas.
- Appointed new Board member Dr. Mani
Mohindru.
- Strengthened balance sheet with
approximately $108 million raised from a follow-on public equity
offering.
Anticipated Events
- Report initial data from the
praluzatamab ravtansine (CX-2009) Phase 2 study in the fourth
quarter of 2021.
- Report initial data from the
CX-2029 Phase 2 expansion study in the fourth quarter of 2021.
- Submit IND applications for CX-2043
and CX-904 in late 2021.
- Virtual analyst and investor
briefing with Key Opinion Leaders in April 2021 to discuss our
Probody technology platform with focus on praluzatamab ravtansine
and CX-2029.
Fourth Quarter and Full Year 2020
Financial ResultsCash, cash equivalents and short-term
investments totaled $316.1 million as of December 31, 2020,
compared to $296.1 million as of December 31, 2019. In January
2021, the Company closed on its previously announced underwritten
public offering of common stock with net proceeds of approximately
$93.6 million. In February 2021, the underwriters exercised in full
the option to purchase additional shares of common stock resulting
in additional net proceeds of $14.1 million to the Company.
Total revenues were $16.4 million and $100.4
million for the three months and year ended December 31, 2020,
respectively, compared to $8.3 million and $57.5 million for the
corresponding periods in 2019. The net increase in total revenues
were primarily driven by an increase in the percentage of
completion of the CD71 Co-Development and Licensing Agreement with
AbbVie and the recognition of revenue from the Collaboration and
License Agreement with Astellas entered into in March 2020.
Research and development expenses decreased by
$14.4 million and $18.7 million during the three months and year
ended December 31, 2020, respectively, to $22.0 million and $112.9
million, compared to $36.4 million and $131.6 million for the
corresponding periods in 2019. The decreases were largely
attributed to a decrease in clinical trial activities primarily due
to the COVID-19 pandemic.
General and administrative expenses were
essentially flat during the three months and year ended December
31, 2020, amounting to $9.1 million and $36.0 million,
respectively, compared to $9.2 million and $36.8 million for the
corresponding periods in 2019.
Conference Call & Webcast
InformationCytomX management will host a conference call
today at 5:00 p.m. ET (2:00 p.m. PT). Interested parties may access
the live webcast of the conference call from the Events and
Presentations page of CytomX's website at www.cytomx.com or by
dialing 1-877-809-6037 (U.S. and Canada) or 1-615-247-0221
(International) using the passcode 5558715. An archived replay of
the webcast will be available on the Company’s website until March
3, 2021.
About CytomX TherapeuticsCytomX
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
conditionally activated antibody therapeutics, based on our
Probody® technology platform, for the treatment of cancer. CytomX
has strategic drug discovery and development collaborations with
AbbVie, Amgen, Astellas, and Bristol Myers Squibb.
Probody therapeutics are conditionally activated
antibodies 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 comprises
five assets, four of which are in Phase 2 clinical studies.
First-in-class product candidates against previously undruggable
targets include a CD166-targeting conditionally activated
antibody-drug conjugate wholly owned by CytomX (praluzatamab
ravtansine, CX-2009) and a CD71-targeting conditionally activated
antibody-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 Probodies,
BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, and
our wholly-owned conditionally activated anti-PD-L1 antibody,
pacmilimab (CX-072). For additional information about CytomX
Therapeutics, visit www.cytomx.com and follow us on LinkedIn and
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. 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 and BMS-986288, 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 and
BMS-986288, and the timing of the commencement of clinical trials
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 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, and pacmilimab
(CX-072); 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 February 24, 2021. 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.
CytomX Contact:Chau Cheng, PhD
MBAVP, Investor Relations & Corp.
Communicationsccheng@cytomx.comDirect: (650) 273-4999
Investor and Media
Contact:Stern Investor RelationsStephanie
Ascherstephanie.ascher@sternir.com212-362-1200
CYTOMX THERAPEUTICS,
INC.STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(in thousands, except share and per share
data)
|
|
Year Ended December 31, |
|
|
|
2020 |
|
|
2019 |
|
|
2018 |
|
Revenues |
|
$ |
100,362 |
|
|
$ |
57,489 |
|
|
$ |
59,502 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
112,936 |
|
|
|
131,619 |
|
|
|
103,866 |
|
General and administrative |
|
|
36,031 |
|
|
|
36,765 |
|
|
|
33,510 |
|
Total operating expenses |
|
|
148,967 |
|
|
|
168,384 |
|
|
|
137,376 |
|
Loss from operations |
|
|
(48,605 |
) |
|
|
(110,895 |
) |
|
|
(77,874 |
) |
Interest income |
|
|
1,836 |
|
|
|
8,365 |
|
|
|
7,641 |
|
Other expense, net |
|
|
(27 |
) |
|
|
(135 |
) |
|
|
(68 |
) |
Loss before income taxes |
|
|
(46,796 |
) |
|
|
(102,665 |
) |
|
|
(70,301 |
) |
Provision for (benefit from) income taxes |
|
|
(13,911 |
) |
|
|
(427 |
) |
|
|
14,303 |
|
Net loss |
|
$ |
(32,885 |
) |
|
$ |
(102,238 |
) |
|
$ |
(84,604 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.71 |
) |
|
$ |
(2.26 |
) |
|
$ |
(2.03 |
) |
Shares used to compute net loss
per share, basic and diluted |
|
|
46,145,563 |
|
|
|
45,335,927 |
|
|
|
41,664,382 |
|
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on short-term investments, net of tax |
|
|
(104 |
) |
|
|
139 |
|
|
|
1 |
|
Impact of adoption of new accounting pronouncement |
|
|
— |
|
|
|
11 |
|
|
|
— |
|
Total comprehensive loss |
|
$ |
(32,989 |
) |
|
$ |
(102,088 |
) |
|
$ |
(84,603 |
) |
CYTOMX THERAPEUTICS,
INC.BALANCE SHEETS(in thousands,
except share and per share data)
|
|
December 31, |
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
191,859 |
|
|
$ |
188,425 |
|
Short-term investments |
|
|
124,260 |
|
|
|
107,720 |
|
Accounts receivable |
|
|
798 |
|
|
|
13 |
|
Prepaid expenses and other current assets |
|
|
7,096 |
|
|
|
7,177 |
|
Total current assets |
|
|
324,013 |
|
|
|
303,335 |
|
Property and equipment, net |
|
|
6,950 |
|
|
|
7,372 |
|
Intangible assets, net |
|
|
1,167 |
|
|
|
1,312 |
|
Goodwill |
|
|
949 |
|
|
|
949 |
|
Restricted cash |
|
|
917 |
|
|
|
917 |
|
Operating lease right-of-use
asset |
|
|
22,495 |
|
|
|
25,382 |
|
Other assets |
|
|
2,172 |
|
|
|
2,015 |
|
Total assets |
|
$ |
358,663 |
|
|
$ |
341,282 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,996 |
|
|
$ |
4,158 |
|
Accrued liabilities |
|
|
23,059 |
|
|
|
30,051 |
|
Deferred revenues, current portion |
|
|
74,869 |
|
|
|
51,381 |
|
Total current liabilities |
|
|
100,924 |
|
|
|
85,590 |
|
Deferred revenue, net of current
portion |
|
|
186,261 |
|
|
|
178,858 |
|
Operating lease liabilities -
long term |
|
|
21,675 |
|
|
|
24,871 |
|
Other long-term liabilities |
|
|
— |
|
|
|
850 |
|
Total liabilities |
|
|
308,860 |
|
|
|
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 December 31, 2020 and 2019 |
|
|
— |
|
|
|
— |
|
Common stock, $0.00001 par value;
150,000,000 and 75,000,000 shares authorized at December 31, 2020
and 2019, respectively; 48,251,819 and 45,523,088 shares issued and
outstanding at December 31, 2020 and 2019, respectively |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
499,964 |
|
|
|
468,285 |
|
Accumulated other comprehensive income (loss) |
|
|
(47 |
) |
|
|
57 |
|
Accumulated deficit |
|
|
(450,115 |
) |
|
|
(417,230 |
) |
Total stockholders' equity |
|
|
49,803 |
|
|
|
51,113 |
|
Total liabilities and
stockholders' equity |
|
$ |
358,663 |
|
|
$ |
341,282 |
|
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