- Plans to Initiate Clinical Development
for CAR T-Cell Program in Osteosarcoma in 2018 –
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
second quarter ending June 30, 2017, and provided a clinical and
pipeline update.
“We’ve continued to make important progress on each of our three
development programs,” said Mike Sherman, President and CEO of
Endocyte. “Dr. Michael Jensen at the Seattle Children’s Research
Institute has exceeded our expectations in the breadth of work he
has completed in optimizing the vector to be used in our chimeric
antigen receptor T-cell (CAR T-cell) therapy, and we are happy to
report that we expect to initiate the CAR T-cell manufacturing
process for clinical supply in the fourth quarter of this year. In
addition, we have filed an Investigational New Drug (IND)
application for EC2629, which we believe is the first agent in
development that simultaneously targets cancer cells and the tumor
associated macrophages (TAMs) that support and protect them – an
approach that could continue to evolve the immunotherapy treatment
landscape. Finally, we expect to complete enrollment of
taxane-exposed prostate cancer patients in the EC1169,
PSMA-tubulysin expansion trial this fall.”
“We believe our pipeline has significant potential to create
value and we are committed to effective, timely execution in
bringing these assets forward through clinical development and
identifying paths to accelerate value-driving catalysts. With this
in mind, our strategy is to select receptor-positive patients in
highly-targeted indications from the beginning of development,
including during dose escalation,” continued Mr. Sherman. “We will
also continue to objectively measure our pipeline investments
relative to opportunities to outlicense assets or access external
opportunities to ensure we are deploying capital productively.”
Development Programs Overview
CAR T-Cell (Bi-specific adaptor molecule):
Today, Endocyte announced that Dr. Michael Jensen of Seattle
Children’s Research Institute will lead the clinical evaluation of
Endocyte’s first CAR T-cell adaptor molecule in patients with
osteosarcoma. This is primarily a pediatric indication with a
significant need for new therapeutic options. Recent results from
tumor micro-array analysis and human intravital fluorescent imaging
studies have confirmed this disease as positive for the folate
receptor, the target of Endocyte’s first bi-specific adaptor.
Pre-clinical evaluations for the CAR T-cell program by Dr. Jensen
are expected to be completed in the second half of 2017, in
anticipation of a potential IND filing in 2018. Multiple additional
adaptor molecules designed to be directed to distinct tumor targets
including, potentially, PSMA, NK1R and others, are in development
through the company’s collaboration with Purdue University.
In April, Endocyte announced new research in a late-breaking
poster session at the American Association for Cancer Research
(AACR) Annual Meeting on this application of Endocyte's SMDC
technology. Data demonstrated that Endocyte’s bi-specific adaptor
molecules can mitigate or eliminate adverse cytokine storms in
animal models which could meaningfully improve the safety and
tolerability of CAR T-cell therapies.
EC1169 (PSMA-targeted tubulysin): Endocyte is
currently enrolling a phase 1 expansion cohort of 40 metastatic
castration-resistant prostate cancer (mCRPC) patients who have
previously been treated with a taxane-based therapy. Data presented
at the annual meeting of the American Society of Clinical Oncology
(ASCO) in June demonstrated EC1169’s anti-tumor activity
particularly in patients with previous exposure to taxane therapy.
Endocyte stopped enrollment of taxane-naïve mCRPC patients in the
trial in June. Updated interim results will be presented at the
annual meeting of the European Society for Medical Oncology (ESMO)
in September. This presentation is expected to be an incremental
update to data presented at ASCO a few months prior. Completion of
enrollment is expected in the fall.
EC2629 (Folate-targeted PBD): Endocyte recently
filed an IND with the U.S. FDA and is planning to initiate a phase
1 clinical trial in patients selected as positive for the folate
receptor in cancers where TAMs are known to be prevalent in the
tumor micro-environment, for example, breast, endometrial, ovarian,
and non-small cell lung cancers. This novel agent leverages a
proprietary DNA crosslinking warhead targeted to cancer cells and
the TAMs that both support their growth as well as protect them
from the immune system. This mechanism is particularly compelling
in light of recent research that has identified mechanisms by which
TAMs can mediate resistance to the use of checkpoint inhibitor
therapies such as PD-1 and PD-L1.
Financial Expectations
The company anticipates its cash, cash equivalents and
investments balance at the end of 2017 to be approximately $105
million. As the full expense impact of the company’s restructuring
is expected to be realized by the end of the fourth quarter of
2017, the company anticipates cash expenses to be approximately $5
million per quarter prior to potential increases associated with
advancing clinical trials and new investment opportunities
currently under evaluation.
Second Quarter 2017 Financial Results
Endocyte reported a net loss of $11.7 million, or $0.28 per
basic and diluted share, for the second quarter of 2017, compared
to a net loss of $14.0 million, or $0.33 per basic and diluted
share for the same period in 2016.
In June 2017, the company stopped enrollment in its EC1456 phase
1b trial as the assessment of trial data did not yield the level of
clinical activity necessary to support continued advancement of
EC1456. The company is, however, continuing enrollment of a small
number of patients in its EC1456 ovarian cancer surgical study to
inform other SMDC programs in development. In addition, in June,
Endocyte narrowed the focus of its EC1169 development program,
refocused its efforts on two pre-clinical programs, and reduced its
workforce by approximately 40% to align resources to focus
aggressively on the company’s highest value opportunities while
maintaining key capabilities. Endocyte recorded $2.3 million of
restructuring expenses for the three months ended June 30, 2017 as
follows:
- Included in research and development expenses were expenses for
employee termination benefits of $0.9 million, $0.9 million for the
remaining EC1456 phase 1b trial expenses, including site close-out
expenses, $0.3 million related to other restructuring expenses, and
$0.1 million related to fixed asset impairment charges; and
- Included in general and administrative expenses were expenses
for employee termination benefits of $0.1 million.
Research and development expenses were $8.7 million for the
second quarter of 2017, compared to $6.8 million for the same
period in 2016. The increase was primarily attributable to $2.2
million of expenses recorded in June due to the company’s
restructuring relating primarily to severance for the workforce
reduction, EC1456 trial termination expenses and fixed asset
impairment charges. Other increases included expenses for the
EC1169 phase 1 trial, development of EC2629 and other pre-clinical
and general research. These increases were partially offset by a
decrease in non-cash stock compensation expense as a result of
employee terminations since the second quarter of 2016.
General and administrative expenses were $3.3 million for the
second quarter of 2017, compared to $7.4 million for the same
period in 2016. The decrease was due to a decrease in compensation
expense, including non-cash stock compensation expense and
severance expense related to the resignation of our former Chief
Executive Officer in June of 2016.
Cash, cash equivalents and investments were $118.4 million at
June 30, 2017, compared to$154.6 million at June 30, 2016, and
$138.2 million at December 31, 2016.
Conference Call
Endocyte management will host a conference call today at 4:30
p.m. EDT.
U.S. and Canadian participants: (877)
845-0711International:
(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 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. In addition, the company
continues to pursue applications of the SMDC platform and is
working to bring assets toward clinical development in several
areas, including EC2629, its dual-targeted DNA crosslinker drug
that can attack both TAMs and cancer cells, and its CAR T-Cell SMDC
adaptor platform. 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, future use of capital, 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 and
those relating to future IND filings. 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 |
|
For the
Six Months |
|
|
|
Ended June
30, |
|
Ended June
30, |
|
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
Collaboration
revenue |
|
$ |
13 |
|
|
$ |
13 |
|
|
$ |
25 |
|
|
$ |
25 |
|
|
Costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
6,788 |
|
|
|
8,655 |
|
|
|
13,319 |
|
|
|
16,649 |
|
|
General
and administrative |
|
|
7,394 |
|
|
|
3,306 |
|
|
|
11,214 |
|
|
|
7,051 |
|
|
Total costs and
expenses |
|
|
14,182 |
|
|
|
11,961 |
|
|
|
24,533 |
|
|
|
23,700 |
|
|
Loss from
operations |
|
|
(14,169 |
) |
|
|
(11,948 |
) |
|
|
(24,508 |
) |
|
|
(23,675 |
) |
|
Interest income,
net |
|
|
208 |
|
|
|
234 |
|
|
|
397 |
|
|
|
469 |
|
|
Other expense, net |
|
|
(1 |
) |
|
|
(30 |
) |
|
|
(4 |
) |
|
|
(27 |
) |
|
Net loss |
|
$ |
(13,962 |
) |
|
$ |
(11,744 |
) |
|
$ |
(24,115 |
) |
|
$ |
(23,233 |
) |
|
Net loss per share -
basic and diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.28 |
) |
|
$ |
(0.57 |
) |
|
$ |
(0.55 |
) |
|
Comprehensive loss |
|
$ |
(13,897 |
) |
|
$ |
(11,726 |
) |
|
$ |
(23,940 |
) |
|
$ |
(23,227 |
) |
|
Weighted average number
of common shares used in net loss per share calculation – basic and
diluted |
|
|
42,178,537 |
|
|
|
42,503,584 |
|
|
|
42,144,182 |
|
|
|
42,469,337 |
|
|
Endocyte, Inc. |
|
Balance Sheets |
|
(in thousands) |
|
|
|
|
|
As of December 31, |
|
|
As of June 30, |
|
|
|
2016 |
|
|
2017 |
|
|
|
|
|
|
(unaudited) |
|
Assets |
|
|
|
|
|
|
|
|
Cash,
cash equivalents and investments |
|
$ |
138,207 |
|
|
$ |
118,395 |
|
Other
assets |
|
|
5,287 |
|
|
|
3,545 |
|
Total assets |
|
$ |
143,494 |
|
|
$ |
121,940 |
|
|
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities |
|
$ |
5,562 |
|
|
$ |
5,239 |
|
Deferred
revenue and other liabilities, net of current portion |
|
|
785 |
|
|
|
757 |
|
Total
stockholders’ equity |
|
|
137,147 |
|
|
|
115,944 |
|
Total liabilities and
stockholders’ equity |
|
$ |
143,494 |
|
|
$ |
121,940 |
|
|
|
|
|
|
|
|
|
|
Contact:
Stephanie Ascher, Stern Investor Relations, Inc., (212) 362-1200, stephanie@sternir.com
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