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
first quarter ending March 31, 2017, and provided a clinical and
pipeline update.
“We look forward to providing safety and efficacy updates for
our clinical trials of both EC1169 and EC1456 at the Annual Meeting
of the American Society of Clinical Oncology (ASCO) next month,”
said Mike Sherman, president and CEO at Endocyte. “In addition, we
continue to discover compelling applications of the SMDC platform
and are working to more rapidly bring assets toward clinical
development in several exciting areas, to drive more value from our
pipeline. These include our dual-targeted DNA crosslinker drug that
can attack both tumor associated macrophages (TAMs) and cancer
cells, EC2629, and our chimeric antigen receptor T-cell (CAR
T-cell) SMDC adaptor platform.”
“Enrollment in the expansion phase of the EC1169 trial in
prostate cancer continues to progress well, and we recently
completed our work with EC1456 exploring multiple dosing
schedules,” added Dr. Alison Armour, Endocyte’s chief medical
officer. “We also enrolled the first patient in the study of EC1456
in ovarian cancer patients undergoing surgery to provide
tissue-based characterization following drug administration.”
Lead SMDC Programs
EC1169 (PSMA-targeted tubulysin): Enrolling
patients in the expansion phase of the EC1169 trial in up to 50
taxane-exposed metastatic castration-resistant prostate cancer
(mCRPC) patients and up to 50 taxane-naïve mCRPC patients at a
maximum clinical dose of 6.5 mg/m2 once per week. The primary
endpoint of this expansion phase is radiographic progression-free
survival (rPFS), with a target of 5 months for taxane-naïve mCRPC
patients and 3 months for taxane-exposed mCRPC 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
on PSMA positive patients.
EC1456
(folate
receptor-targeted
tubulysin): Enrolling expansion
cohort of up to 40 folate receptor-positive (FR-positive) non-small
cell lung cancer (NSCLC) patients, as determined by an etarfolatide
scan, to receive the maximum clinical dose of 6.0 mg/m2 twice per
week. Patients included in this expansion phase of the trial will
have received first-line chemotherapy and may have also been
treated with anti-programmed death-1 (anti-PD-1) therapy. Endocyte
is also conducting an ovarian cancer surgical study to characterize
EC1456 at the tumor level through a multifaceted analysis of
collected tissue samples after administration of the drug.
Immuno-oncology Pipeline
EC2629: Pre-clinical development currently
underway with a potential Investigational New Drug (IND) filing in
mid-2017. EC2629 leverages a proprietary warhead with a dual
mechanism of action: targeting both TAMs and FR-positive cancer
cells.
CAR T-Cell Development Program: Continued
progress with next-generation CAR T-cell therapeutic platform, in
collaboration with leading experts in the field at Seattle
Children's Research Institute. Endocyte announced new research in a
late-breaking poster session at the American Association for Cancer
Research (AACR) Annual Meeting in April 2017, on the application of
Endocyte's SMDC technology. Data demonstrated that Endocyte’s
bi-specific adaptor molecules can mitigate or eliminate cytokine
storms in animal models and could meaningfully improve the safety
and tolerability of CAR T-cell therapies. Pre-clinical evaluations
for the CAR T-cell program by Dr. Michael Jensen are expected to be
completed in the second half of 2017, in anticipation of a
potential IND filing in 2018.
First Quarter 2017 Financial Results
Endocyte reported a net loss of $11.5 million, or $0.27 per
basic and diluted share, for the first quarter of 2017, compared to
a net loss of $10.2 million, or $0.24 per basic and diluted share
for the same period in 2016.
Research and development expenses were $8.0 million for the
first quarter of 2017, compared to $6.5 million for the same period
in 2016. The increase was primarily attributable to increases in
expenses related to the EC1169 phase 1 trial, including drug
manufacturing expenses, expenses related to the development of
EC2629 and other pre-clinical work and general research, and
expenses related to the EC1456 phase 1 trial, which were partially
offset by a decrease related to non-cash stock-based compensation
expenses.
General and administrative expenses were $3.7 million for the
first quarter of 2017, compared to $3.8 million for the same period
in 2016. The slight decrease was primarily attributable to a
decrease in compensation expense, which was partially offset by an
increase in expenses related to professional fees.
Cash, cash equivalents and investments were $127.6 million at
March 31, 2017, compared to$163.3 million at March 31, 2016, and
$138.2 million at December 31, 2016.
Financial Expectations
The company anticipates its cash balance at the end of 2017 to
be approximately $100 million.
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.
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.
Conference Call
Endocyte management will host a conference call today at 8:30
a.m. EDT.
U.S. and Canadian
participants: |
(877) 845-0711 |
International: |
(760) 298-5081 |
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 Information
Endocyte 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 March
31, |
|
|
|
|
|
2016 |
|
|
|
2017 |
|
|
|
|
|
|
|
Collaboration
revenue |
|
|
|
$ |
12 |
|
|
|
$ |
12 |
|
Costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
|
|
6,531 |
|
|
|
|
7,994 |
|
General
and administrative |
|
|
|
|
3,820 |
|
|
|
|
3,745 |
|
Total costs and
expenses |
|
|
|
|
10,351 |
|
|
|
|
11,739 |
|
Loss from
operations |
|
|
|
|
(10,339 |
) |
|
|
|
(11,727 |
) |
|
|
|
|
|
|
|
|
|
|
|
Interest income,
net |
|
|
|
|
189 |
|
|
|
|
235 |
|
Other income (expense),
net |
|
|
|
|
(3 |
) |
|
|
|
3 |
|
Net loss |
|
|
|
$ |
(10,153 |
|
) |
|
$ |
(11,489 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted |
|
|
|
$ |
(0.24 |
) |
|
|
$ |
(0.27 |
) |
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
$ |
(10,043 |
) |
|
|
$ |
(11,501 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted average number
of common shares used in net loss per share – basic and
diluted: |
|
|
|
|
42,109,828 |
|
|
|
|
42,434,709 |
|
Endocyte, Inc.Balance
Sheets(in thousands) |
|
|
|
|
|
|
|
|
|
|
As of December 31, |
|
|
As of March 31, |
|
|
|
2016 |
|
|
2017 |
|
|
|
|
|
|
(unaudited) |
|
Assets |
|
|
|
|
|
|
|
|
Cash,
cash equivalents and investments |
|
$ |
138,207 |
|
|
$ |
127,562 |
|
Other
assets |
|
|
5,287 |
|
|
|
4,825 |
|
Total assets |
|
$ |
143,494 |
|
|
$ |
132,387 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities |
|
$ |
5,562 |
|
|
$ |
4,915 |
|
Deferred
revenue and other liabilities, net of current portion |
|
|
785 |
|
|
|
770 |
|
Total
stockholders’ equity |
|
|
137,147 |
|
|
|
126,702 |
|
Total liabilities and
stockholders’ equity |
|
$ |
143,494 |
|
|
$ |
132,387 |
|
Contact:
Stephanie Ascher, Stern Investor Relations, Inc., (212) 362-1200, stephanie@sternir.com
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