Endocyte, Inc. (NASDAQ:ECYT), a leader in developing targeted small
molecule drug conjugates (SMDCs) and companion imaging agents for
personalized therapy, today announced financial results for the
fourth quarter ending December 31, 2016, and provided a clinical
and business update.
“We are pleased to report progress on several aspects of the
business during the last several weeks,” commented Mike Sherman,
president and CEO at Endocyte. “The separately announced
collaboration with Seattle Children’s Research Institute and Dr.
Michael Jensen, an innovator and thought leader in the field of
chimeric antigen receptor T-cell (CAR T-cell) immunotherapies, is
an indication of the promise of our technology and a reflection of
our commitment to establishing partnerships intended to bring early
stage programs to the clinic more rapidly and drive more value from
our pipeline. Mike Andriole joining us as chief financial officer
also adds significant experience and capacity to pursue value
driving partnerships going forward.”
“We also anticipate receiving additional clinical data on our
lead assets, EC1169 and EC1456, during 2017 as we advance two
additional agents toward the clinic,” continued Mr. Sherman.
EC1169 (PSMA-tubulysin) Program Outline
- Currently enrolling patients in the expansion phase of the
EC1169 trial in up to 50 second-line chemotherapy and up to 50
taxane-naïve metastatic castrate-resistant prostate cancer (mCRPC)
patients at a maximum clinical once per week dose of 6.5 mg/m2
- Patients are scanned with Endocyte’s proprietary imaging agent,
EC0652, to identify the presence of disease that expresses
prostate-specific membrane antigen (PSMA)
- Primary endpoint of this expansion phase is radiographic
progression-free survival (rPFS), measured at 5 months for
taxane-naïve mCRPC patients and at 3 months for second-line
chemotherapy patients
- Secondary endpoints which will provide earlier insight into
drug activity include overall response rates as measured by
response evaluation criteria in solid tumors (RECIST) 1.1 and
prostate-specific antigen (PSA)
- Enrollment is not limited based on the results of the scan with
EC0652 but primary endpoints of the trial are to be assessed in
PSMA-positive patients
EC1456 (Folate-tubulysin) Program Outline
- Currently enrolling expansion cohort of up to 40
folate-receptor (FR) positive non-small cell lung cancer (NSCLC)
patients, as determined by an etarfolatide scan, to receive the
maximum clinical twice per week dose of 6.0 mg/m2
- Patients included in this expansion phase of the trial will
have received first-line chemotherapy and may have also been
treated with anti-PD-1 therapy
- Exploring a more frequent dosing schedule, four times per week,
in indications that are typically FR-positive, such as ovarian and
endometrial cancers
- Also conducting an ovarian cancer surgical study to assess
various attributes of the drug release within targeted tumors
Upcoming Expected Milestones
- Safety and efficacy updates for both EC1169 and EC1456 ongoing
clinical trials expected at the Annual Meeting of the American
Society of Clinical Oncology in June, 2017
- Updated pre-clinical data for CAR T-cell program expected to be
presented at a medical conference in the first half of 2017
- Expect to file Investigational New Drug (IND) application for
EC2629 in mid 2017. EC2629 leverages a proprietary warhead
with a dual mechanism of action: targeting both FR+ cancer cells
and tumor associated macrophages (TAMs)
- Completion of pre-clinical evaluations for CAR T-cell program
expected in second half of 2017
- Initiation of enrollment for EC2629 phase 1 trial expected in
second half of 2017
- Pre-clinical preparatory work on EC2319 in anticipation of
potential IND in 2018. EC2319 targets and disables activated
macrophages which otherwise produce pro-inflammatory cytokines
associated with chronic inflammatory disease
Fourth Quarter 2016 Financial Results
Endocyte reported a net loss of $11.1 million, or $0.26 per
basic and diluted share, for the fourth quarter of 2016, compared
to a net loss of $9.8 million, or $0.23 per basic and diluted share
for the same period in 2015.
Research and development expenses were $8.2 million for the
fourth quarter of 2016, compared to $6.4 million for the same
period in 2015. The increase was primarily attributable to
increases in expenses related to the EC1169 phase 1 trial,
including drug manufacturing expenses.
General and administrative expenses were $3.1 million for the
fourth quarter of 2016, compared to $3.5 million for the same
period in 2015. The decrease was primarily attributable to a
decrease in compensation expense, which was partially offset by an
increase in expenses related to patent and recruiting
fees.
Cash, cash equivalents and investments were $138.2 million at
December 31, 2016, compared to $146.7 million at September 30,
2016, and $173.6 million at December 31, 2015.
Financial Expectations
The company anticipates its cash balance at the end of 2017 to
be approximately $100 million.
About EC1456 and
etarfolatide
EC1456 is an investigational therapeutic SMDC constructed of a
high affinity FR-targeting ligand conjugated through a spacer and
bioreleasable linker system to a potent cytotoxic microtubule
inhibitor, TubBH. Patient FR-status is determined using the
investigational companion imaging agent, etarfolatide.
About EC1169 and EC0652
EC1169 is an investigational therapeutic SMDC constructed of a
high affinity prostate specific membrane antigen (PSMA)-targeting
ligand conjugated through a bioreleasable linker system to a potent
microtubule inhibitor, tubulysin B hydrazide (TubBH). Patient
PSMA-status is determined using the investigational companion
imaging agent, EC0652.
Conference Call
Endocyte management will host a conference call today at 8:30
a.m. EST.
U.S. and Canadian
participants: |
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(877) 845-0711 |
International: |
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(760) 298-5081
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A live, listen-only webcast of the conference call may also be
accessed by visiting the Investors & News section of the
Endocyte website, www.endocyte.com.
The webcast will be recorded and available on the company's
website for 90 days following the call.
Website InformationEndocyte
routinely posts important information for investors on its
website, www.endocyte.com, in the “Investors & News”
section. Endocyte uses this website as a means of disclosing
material information in compliance with its disclosure obligations
under Regulation FD. Accordingly, investors should monitor
the “Investors & News” section of Endocyte’s website, in
addition to following its press releases, SEC filings, public
conference calls, presentations and webcasts. The information
contained on, or that may be accessed through, Endocyte’s website
is not incorporated by reference into, and is not a part of, this
document.
About Endocyte
Endocyte is a biopharmaceutical company and leader in developing
targeted therapies for the treatment of cancer and other serious
diseases. Endocyte uses its proprietary drug conjugation
technology to create novel SMDCs and companion imaging agents for
personalized targeted therapies. The company’s SMDCs actively
target receptors that are over-expressed on diseased cells relative
to healthy cells. This targeted approach is designed to
enable the treatment of patients with highly active drugs at
greater doses, delivered more frequently and over longer periods of
time than would be possible with the untargeted drug alone.
The companion imaging agents are designed to identify patients
whose disease over-expresses the target of the therapy and who are
therefore more likely to benefit from treatment. For additional
information, please visit Endocyte’s website at
www.endocyte.com.
Forward Looking Statements
Certain of the statements made in this press release are forward
looking, such as those, among others, relating to future spending,
future cash balances, the successful completion of current and
future clinical trials, the enrollment period for, and availability
and reporting, of data from ongoing and future clinical trials, and
the company's future development plans including those relating to
the completion of pre-clinical development in preparation for
possible future clinical trials. Actual results or developments may
differ materially from those projected or implied in these
forward-looking statements. Factors that may cause such a
difference include risks that the company may experience delays in
the completion of its clinical trials (whether caused by
competition, adverse events, patient enrollment rates, shortage of
clinical trial materials, regulatory issues or other factors);
risks that data from its clinical trials may not be indicative of
subsequent clinical trial results; risks related to the safety and
efficacy of the company’s product candidates; risks that early
stage pre-clinical data may not be indicative of subsequent data
when expanded to additional pre-clinical models or to subsequent
clinical data; risks that evolving competitive activity and
intellectual property landscape may impair the company's ability to
capture value for the technology; risks that expectations and
estimates turn out to be incorrect, including estimates of the
potential markets for the company’s product candidates, estimates
of the capacity of manufacturing and other facilities required to
support its product candidates, projected cash needs, and expected
future revenues, operations, expenditures and cash position. More
information about the risks and uncertainties faced by Endocyte,
Inc. is contained in the company’s periodic reports filed with the
Securities and Exchange Commission. Endocyte, Inc. disclaims any
intention or obligation to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Endocyte, Inc. |
|
Statements of Operations |
|
(dollars in thousands, except per share amounts) |
|
(unaudited) |
|
|
|
|
|
For the Three Months Ended December
31, |
|
|
For the Twelve Months Ended December
31, |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenue |
|
$ |
12 |
|
|
|
$ |
12 |
|
|
|
$ |
70 |
|
|
|
$ |
70 |
|
Costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
6,386 |
|
|
|
|
8,188 |
|
|
|
|
26,309 |
|
|
|
|
27,492 |
|
General
and administrative |
|
|
3,527 |
|
|
|
|
3,096 |
|
|
|
|
15,734 |
|
|
|
|
17,298 |
|
Total costs and
expenses |
|
|
9,913 |
|
|
|
|
11,284 |
|
|
|
|
42,043 |
|
|
|
|
44,790 |
|
Loss from
operations |
|
|
(9,901 |
) |
|
|
|
(11,272 |
) |
|
|
|
(41,973 |
) |
|
|
|
(44,720 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income,
net |
|
|
162 |
|
|
|
|
232 |
|
|
|
|
652 |
|
|
|
|
861 |
|
Other income (expense),
net |
|
|
(55 |
) |
|
|
|
(25 |
) |
|
|
|
51 |
|
|
|
|
(29 |
) |
Net loss |
|
$ |
(9,794 |
) |
|
|
$ |
(11,065 |
) |
|
|
$ |
(41,270 |
) |
|
|
$ |
(43,888 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
|
$ |
(0.23 |
) |
|
|
$ |
(0.26 |
) |
|
|
$ |
(0.98 |
) |
|
|
$ |
(1.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(9,897 |
) |
|
|
$ |
(11,137 |
) |
|
|
$ |
(41,205 |
) |
|
|
$ |
(43,849 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Weighted average number
of common shares used in net loss – basic and diluted per
share: |
|
|
41,984,763 |
|
|
|
|
42,289,453 |
|
|
|
|
41,939,504 |
|
|
|
|
42,210,643 |
|
Endocyte, Inc. |
|
Balance Sheets |
|
(in thousands) |
|
|
|
|
|
As of December 31, |
|
|
As of December 31, |
|
|
|
2015 |
|
|
2016 |
|
|
|
|
|
|
(unaudited) |
|
Assets |
|
|
|
|
|
|
|
|
Cash,
cash equivalents and investments |
|
$ |
173,600 |
|
|
$ |
138,207 |
|
Other
assets |
|
|
4,786 |
|
|
|
5,287 |
|
Total assets |
|
$ |
178,386 |
|
|
$ |
143,494 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities |
|
$ |
6,189 |
|
|
$ |
5,562 |
|
Deferred
revenue and other liabilities, net of current portion |
|
|
851 |
|
|
|
785 |
|
Total
stockholders’ equity |
|
|
171,346 |
|
|
|
137,147 |
|
Total liabilities and
stockholders’ equity |
|
$ |
178,386 |
|
|
$ |
143,494 |
|
Contact:
Stephanie Ascher, Stern Investor Relations, Inc., (212) 362-1200, stephanie@sternir.com
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