CytomX Announces Second Quarter 2016 Financial Results
03 Agosto 2016 - 3:01PM
CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical
company developing investigational Probody™ therapeutics for the
treatment of cancer, today reported second quarter 2016 financial
results.
“We achieved all targeted milestones in our pipeline this
quarter as we continue to execute and drive our lead, wholly-owned
programs towards the clinic,” said Sean McCarthy, D.Phil.,
president and chief executive officer of CytomX Therapeutics.
“With our transformational Probody technology platform, CytomX
intends to unlock the full potential of antibody therapeutics by
bringing new and differentiated treatment options to cancer
patients.”
As of June 30, 2016, CytomX had cash and cash equivalents and
investments of $195.8 million. The Company continues to expect full
year net cash utilization of $20.0 to $25.0 million in 2016. Based
upon its current operating plan, the Company expects its existing
capital resources will be sufficient to fund operations through
2018.
Business Highlights and Recent Developments
CX-072 (PD-L1 Probody) Program
- The CX-072 IND remains on track to be filed in the second half
of 2016, with an initial set of study sites expected to open by
year-end to support initiation of patient enrollment.
- Preclinical development activities to support clinical trial
initiation are complete, including pre-IND interactions with FDA,
execution of GLP toxicology studies and large-scale GMP
manufacturing of clinical material.
- As CytomX evolves from a research-stage to a clinical-stage
organization, the Company is launching a first-of-its-kind clinical
trial program that enables study sites and physicians to access
CytomX’s wholly-owned Probody therapeutics under one international
umbrella program called PROCLAIM (Probody
Clinical Assessment
In Man).
- The first module within the PROCLAIM program is the open-label,
dose-finding Phase 1/2 study evaluating CX-072 as monotherapy and
in combination with Yervoy® (ipilimumab) or Zelboraf® (vemurafenib)
in anti-PD-(L)1 inhibitor naïve patients with certain cancers.
- To realize the vision of establishing CX-072 as the PD-(L)1
combination therapy of choice, CytomX aims to achieve three goals
as part of the PROCLAIM-072 clinical trial:
- Safety: Demonstrate that CX-072 is well tolerated in patients,
and potentially improves safety, particularly in the combination
setting.
- Anti-cancer activity: Demonstrate initial evidence of CX-072’s
anti-cancer activity as monotherapy and in combination.
- Translational program and Probody platform proof-of-concept:
Explore mechanistic aspects of Probody activity in patients as
observed in preclinical studies.
- Clinical data is expected to begin to emerge in the second half
of 2017 and throughout 2018.
CX-2009 (CD166 Probody Drug Conjugate)
Program
- Plans remain on track for filing an IND for CX-2009, a
first-in-class Probody drug conjugate targeting the highly
expressed tumor antigen, CD166, in the first half of 2017.
- Completed preclinical activities include pre-IND interactions
with FDA, execution of a large-scale GMP manufacturing run for
clinical material and initiation of GLP toxicology studies.
- Clinical data is expected to begin to emerge in the second half
of 2017 and throughout 2018.
Other Pipeline Updates
- The PD-pathway is one of the most important checkpoint pathways
responsible for mediating tumor-induced immune suppression, and
PD-(L)1 inhibitors are becoming the cornerstone of combination
therapy for many types of cancer.
- CX-072 targets tumor-expressed PD-L1. The Company has
previously demonstrated that a Probody targeting T-cell PD-1 can
also elicit potent anti-tumor activity.
- To that end, CytomX expects to nominate a lead candidate for
its PD-1 Probody therapeutic in 2016, and will advance the program
towards the clinic.
Partnerships
- CytomX’s strategy of forming collaborations with major
pharmaceutical companies including AbbVie, Bristol-Myers Squibb and
Pfizer, continues to validate the potential of the Probody platform
to transform antibody therapeutics in cancer.
- CytomX continues to make progress with its partners to advance
Probody therapeutics and believes that there is robust potential
for additional IND filings with partnered programs in 2017 and
2018.
- Given the breadth of potential applications of the Probody
platform, the Company continues to engage prospective partners
regarding additional collaboration opportunities.
Second Quarter Financial ResultsCash, cash
equivalents and investments totaled $195.8 million as of June 30,
2016, compared to $186.7 million as of December 31, 2015. The
increase reflects a $30.0 million upfront payment received from
AbbVie in connection with the collaboration agreements entered in
April 2016, a $10.0 million milestone payment received from
Bristol-Myers Squibb in connection with its third target selection
in January 2016, partially offset by cash used in operations.
Research and development expenses were $12.7 million for the
second quarter of 2016, compared to $5.0 million for the second
quarter of 2015. The increase was primarily attributable to $3.8
million in manufacturing costs for the Company’s CX-072 and CX-2009
programs in preparation for preclinical and clinical studies, $1.5
million in laboratory and professional services, $0.9 million in
non-cash stock-based compensation due to higher stock valuation,
$0.9 million in personnel-related expenses due to an increase in
headcount and $0.5 million in royalty payments to a third party
triggered by the upfront payment in connection with the AbbVie
collaboration agreement. The Company expects the manufacturing
costs for the two programs to decrease in the third quarter and the
costs related to preparation for CX-072 clinical trials to
increase.
General and administrative expenses were $4.6 million for the
second quarter of 2016, compared to $2.6 million for the second
quarter of 2015. The increase was predominantly due to $0.9 million
in non-cash stock based compensation due to higher stock valuation,
$0.8 million in personnel-related expenses due to an increase in
headcount and $0.4 million in additional consulting and
professional service expenses associated with operating as a public
company.
About CytomX TherapeuticsCytomX is an
oncology-focused biopharmaceutical company pioneering a novel class
of investigational antibody therapeutics based on its Probody
technology platform. The company uses the platform to create
proprietary cancer immunotherapies against clinically-validated
targets, as well as to develop first-in-class investigational
cancer therapeutics against novel targets. CytomX believes that its
Probody platform has the potential to improve the combined efficacy
and safety profile of monoclonal antibody modalities, including
cancer immunotherapies, antibody drug conjugates and
T-cell-recruiting bispecific antibodies. Probody therapeutics are
designed to take advantage of unique conditions in the tumor
microenvironment to enhance the tumor-targeting features of an
antibody and reduce drug activity in healthy tissues. The
company’s investigational Probody therapeutics address
clinically-validated cancer targets in immuno-oncology, such as
PD-L1, against which the clinical candidate CX-072 is directed, as
well as novel targets, such as CD-166, that are difficult to drug
without causing damage to healthy tissues. In addition to its
proprietary programs, CytomX is collaborating with strategic
partners including AbbVie, Bristol-Myers Squibb Company, Pfizer
Inc., MD Anderson Cancer Center, and ImmunoGen, Inc. For more
information, visit www.cytomx.com.
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. Our Probody platform is in preclinical
development, and the process by which a preclinical technology
could potentially lead to an approved product is long and subject
to significant risks and uncertainties. Projected net cash
utilization and capital resources are subject to substantial risk
of variance based on a wide variety of factors that can be
difficult to predict. Applicable risks and uncertainties
include those relating to our preclinical research and development
and other risks identified under the heading "Risk Factors"
included in our filings with the SEC. 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.
CYTOMX THERAPEUTICS,
INC.CONDENSED STATEMENTS OF OPERATIONS(in
thousands, except share and per share data)(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues |
|
$ |
2,539 |
|
|
$ |
1,557 |
|
|
$ |
4,322 |
|
|
$ |
2,952 |
|
Revenues from related
parties |
|
|
555 |
|
|
|
486 |
|
|
|
995 |
|
|
|
833 |
|
Total
revenues |
|
|
3,094 |
|
|
|
2,043 |
|
|
|
5,317 |
|
|
|
3,785 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and
development |
|
|
12,705 |
|
|
|
5,033 |
|
|
|
26,070 |
|
|
|
9,697 |
|
General and
administrative |
|
|
4,647 |
|
|
|
2,552 |
|
|
|
9,687 |
|
|
|
4,498 |
|
Total
operating expenses |
|
|
17,352 |
|
|
|
7,585 |
|
|
|
35,757 |
|
|
|
14,195 |
|
Loss from operations |
|
|
(14,258 |
) |
|
|
(5,542 |
) |
|
|
(30,440 |
) |
|
|
(10,410 |
) |
Interest
income |
|
|
660 |
|
|
|
329 |
|
|
|
1,150 |
|
|
|
467 |
|
Interest
expense |
|
|
(465 |
) |
|
|
(408 |
) |
|
|
(818 |
) |
|
|
(638 |
) |
Other income
(expense), net |
|
|
(110 |
) |
|
|
(180 |
) |
|
|
(91 |
) |
|
|
(1,431 |
) |
Loss before provision for
income taxes |
|
|
(14,173 |
) |
|
|
(5,801 |
) |
|
|
(30,199 |
) |
|
|
(12,012 |
) |
Provision
for income taxes |
|
|
3 |
|
|
|
5 |
|
|
|
6 |
|
|
|
5 |
|
Net loss |
|
|
(14,176 |
) |
|
|
(5,806 |
) |
|
|
(30,205 |
) |
|
|
(12,017 |
) |
Accretion to redemption
value and cumulative dividends on preferred stock |
|
|
— |
|
|
|
(1,757 |
) |
|
|
— |
|
|
|
(3,189 |
) |
Net loss attributable to
common stockholders |
|
$ |
(14,176 |
) |
|
$ |
(7,563 |
) |
|
$ |
(30,205 |
) |
|
$ |
(15,206 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
|
$ |
(0.39 |
) |
|
$ |
(7.56 |
) |
|
$ |
(0.84 |
) |
|
$ |
(15.22 |
) |
Shares used to compute net
loss per share attributable to common stockholders, basic and
diluted |
|
|
36,113,363 |
|
|
|
1,001,010 |
|
|
|
36,088,393 |
|
|
|
998,793 |
|
CYTOMX THERAPEUTICS, INC.CONDENSED BALANCE
SHEETS(in thousands, except share and per share
data)(unaudited) |
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
62,379 |
|
|
$ |
59,822 |
|
Short-term
investments |
|
|
133,418 |
|
|
|
126,889 |
|
Accounts
receivable |
|
|
285 |
|
|
|
372 |
|
Related
party accounts receivable |
|
|
113 |
|
|
|
372 |
|
Prepaid
expenses and other current assets |
|
|
3,411 |
|
|
|
2,299 |
|
Total current assets |
|
|
199,606 |
|
|
|
189,754 |
|
Property and equipment,
net |
|
|
3,370 |
|
|
|
3,481 |
|
Intangible assets |
|
|
1,750 |
|
|
|
1,750 |
|
Goodwill |
|
|
949 |
|
|
|
949 |
|
Restricted cash |
|
|
917 |
|
|
|
917 |
|
Other assets |
|
|
268 |
|
|
|
364 |
|
Total assets |
|
$ |
206,860 |
|
|
$ |
197,215 |
|
Liabilities and
Stockholders' Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,426 |
|
|
$ |
4,697 |
|
Accrued
liabilities |
|
|
7,313 |
|
|
|
4,912 |
|
Deferred
revenues, current portion |
|
|
13,485 |
|
|
|
6,130 |
|
Total current
liabilities |
|
|
22,224 |
|
|
|
15,739 |
|
Deferred revenue, net of
current portion |
|
|
82,783 |
|
|
|
54,703 |
|
Deferred tax
liability |
|
|
513 |
|
|
|
507 |
|
Other long-term
liabilities |
|
|
153 |
|
|
|
198 |
|
Total liabilities |
|
|
105,673 |
|
|
|
71,147 |
|
Commitments and
contingencies (Note 11) |
|
|
|
|
|
|
|
|
Preferred stock, $0.00001
par value; 10,000,000 shares authorized and no shares issued and
outstanding at June 30, 2016 and December 31, 2015. |
|
|
— |
|
|
|
— |
|
Common stock, $0.00001 par
value; 75,000,000 shares authorized; 36,187,345 and 36,033,209
shares issued and outstanding at June 30, 2016 and December 31,
2015, respectively |
|
|
1 |
|
|
|
1 |
|
Stockholders
notes receivable |
|
|
— |
|
|
|
(78 |
) |
Additional
paid-in capital |
|
|
248,777 |
|
|
|
243,687 |
|
Accumulated
other comprehensive income / (loss) |
|
|
80 |
|
|
|
(76 |
) |
Accumulated
deficit |
|
|
(147,671 |
) |
|
|
(117,466 |
) |
Total stockholders'
equity |
|
|
101,187 |
|
|
|
126,068 |
|
Total liabilities and
stockholders' equity |
|
$ |
206,860 |
|
|
$ |
197,215 |
|
|
|
|
|
|
|
|
|
|
Corporate Communications Contact:
Canale Communications
Ian Stone
ian@canalecomm.com
619-849-5388
Investor Contact:
Trout Group
Pete Rahmer
prahmer@troutgroup.com
646-378-2973
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