-Initiated
phase 3 VISION study of
177Lu-PSMA-617 in
mCRPC- -Secured
commercial supply of no-carrier-added Lutetium-177 through
2035-
Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company
developing targeted therapeutics for personalized cancer treatment,
today announced financial results for the second quarter ending
June 30, 2018 and provided an operational update.
“During the second quarter, we continued to execute rapidly on
our strategy, initiating the phase 3 VISION study of 177Lu-PSMA-617
and securing a long-term commercial supply agreement for no-carrier
added lutetium, which could support treatment of a potentially
large patient population if approved,” said Mike Sherman president
and CEO of Endocyte. “Additionally, data from 177Lu-PSMA-617 were
prominently featured at key medical meetings during the quarter,
and we are pleased that data continue to suggest a favorable
profile and improved PSA response rates. We also presented key
preclinical data from our CAR-T platform and expect to file an IND
for EC17/CAR T-cell therapy in patients with osteosarcoma in the
fourth quarter this year.”
Second Quarter and Recent Highlights
- Enrolled the first patient in the phase 3 VISION study of
177Lu-PSMA-617 in patients with progressive prostate specific
membrane antigen (PSMA)-positive metastatic castration-resistant
prostate cancer (mCRPC).
- Signed a long-term global supply agreement with ITG Isotope
Technologies Garching GmbH (ITG), for highly purified,
no-carrier-added Lutetium-177 to support both clinical and
commercial supply of 177Lu-PSMA-617, through 2035.
- Announced that multiple presentations related to Endocyte’s
PSMA-617 radioligand therapy were presented at the 2018 Society of
Nuclear Medicine and Molecular Imaging Annual Meeting.
- Announced the publication of data in The Lancet Oncology from
the original 30 patients in the phase 2 trial of 177Lu-PSMA-617
initiated by Professor Michael Hofman of the Peter MacCallum Cancer
Centre (MacCallum study). Relative to previously presented data
from this study, the updated data reflected longer median overall
survival, longer median prostate specific antigen (PSA)
progression-free survival, and higher RECIST soft tissue response
rates. The safety profile of 177Lu-PSMA-617 was similar to that
previously reported.
- Announced the presentation of data at the American Society of
Clinical Oncology Annual Meeting from 50 patients in the MacCallum
study, which included data from 20 additional patients and
demonstrated higher PSA response rates than the initial 30 patients
in the study, as well as consistency in activity regardless of
prior therapies. Survival data from these additional 20
patients were not yet mature.
- Presented data at the American Association for Cancer Research
Annual Meeting, including a late-breaking poster, demonstrating
that EC17/CAR T-cell therapy showed consistent antitumor activity
in human xenografts, with multiple mechanisms for controlling
immune response to potentially mitigate cytokine release
syndrome.
Expected 2018 Milestones
- Publications on additional ongoing investigator-initiated
clinical trials of 177Lu-PSMA-617 in prostate cancer patients
(2018).
- IND for phase 1 trial of EC17/CAR T-cell therapy in patients
with osteosarcoma (4Q 2018).
Second Quarter 2018 Financial Results
Endocyte reported a net loss of $11.6 million, or $0.17 per
basic and diluted share, for the second quarter of 2018, compared
to a net loss of $11.7 million, or $0.28 per basic and diluted
share, for the same period in 2017.
Research and development expenses were $7.6 million for the
second quarter of 2018, compared to $8.7 million for the same
period in 2017. The decrease was primarily attributable to a
strategic portfolio review announced in June 2017 which led to a
reduction in workforce and the discontinuation of certain research
and development activities, including, for the second quarter of
2018 compared to the second quarter of 2017: a decrease of $1.5
million in EC1456 trial expenses; a decrease of $1.3 million in
expenses related to pre-clinical work and general research,
including the development of EC2629; a decrease of $1.0 million in
EC1169 trial expenses; a decrease of $0.5 million in compensation
expense as a result of employee terminations since June 30, 2017;
and a decrease of $0.2 million in manufacturing expense for EC1169
and EC1456. These decreases were partially offset by: an increase
of $3.3 million in expenses related to development of PSMA-617; and
an increase of $0.2 million related to our CAR T-cell therapy
program.
General and administrative expenses were $4.6 million for the
second quarter of 2018, compared to $3.3 million for the same
period in 2017. The increase was primarily attributable to an
increase of $0.5 million in compensation expense, of which $0.4
million related to stock-based compensation charges; an increase of
$0.5 million in legal and professional fees; and an increase of
$0.3 million in other general and administrative fees.
Cash, cash equivalents and investments were $166.8 million at
June 30, 2018, compared to $118.4 million at June 30, 2017, and
$97.5 million at Dec. 31, 2017. Cash, cash equivalents and
investments of $166.8 million at June 30, 2018 included $80.9
million of net proceeds from our public offering of 20,535,714
shares of our common stock that closed in March 2018.
Financial Expectations
The company anticipates its cash, cash equivalents and
investments balance at the end of 2018 to exceed $130 million.
Based on current operational assumptions, Endocyte has sufficient
cash to fund its activities through the expected end of the VISION
trial and potential proof of concept of its EC17/CAR T-cell
therapy.
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 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 personalized treatment of cancer. The
company's drug conjugation technology targets therapeutics and
companion imaging agents specifically to the site of diseased
cells. Endocyte's lead program is a prostate specific membrane
antigen (PSMA)-targeted radioligand therapy, 177Lu-PSMA-617, in
phase 3 for metastatic castration-resistant prostate cancer
(mCRPC). Endocyte also expects to have an Investigational New Drug
application submitted in the fourth quarter of 2018 for its
adaptor-controlled CAR T-cell therapy which will be studied
initially in osteosarcoma. 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, sufficiency of cash,
the timing of initiation, interim assessments and completion of
clinical trials, the enrollment period for, and availability and
reporting of data from, ongoing and future clinical trials, the
occurrence and timing of submissions to, and actions by, regulatory
agencies, estimates of the potential market opportunity for the
company’s product candidates, 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
future sources of supply of raw materials and product candidates to
support clinical and commercial activities. 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 or independent
investigators may experience delays in the initiation or completion
of clinical trials (whether caused by competition, adverse events,
patient enrollment rates, shortage of clinical trial materials,
regulatory issues or other factors); risks that suppliers or other
third party contractors may not fulfill their contractual
obligations on a timely basis or at all; risks that data from
prior 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.
Investor Contact:Michael Schaffzin, Stern
Investor Relations, Inc., (212) 362-1200, michael@sternir.com
|
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, |
|
|
|
2017 |
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
|
Collaboration revenue |
|
$ |
13 |
|
|
$ |
14 |
|
|
$ |
25 |
|
|
$ |
30 |
|
|
Costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
8,655 |
|
|
|
7,625 |
|
|
|
16,649 |
|
|
|
12,880 |
|
|
General and administrative |
|
|
3,306 |
|
|
|
4,631 |
|
|
|
7,051 |
|
|
|
8,409 |
|
|
Total costs
and expenses |
|
|
11,961 |
|
|
|
12,256 |
|
|
|
23,700 |
|
|
|
21,289 |
|
|
Loss from
operations |
|
|
(11,948 |
) |
|
|
(12,242 |
) |
|
|
(23,675 |
) |
|
|
(21,259 |
) |
|
Interest
income, net |
|
|
234 |
|
|
|
720 |
|
|
|
469 |
|
|
|
1,133 |
|
|
Other
expense, net |
|
|
(30 |
) |
|
|
(42 |
) |
|
|
(27 |
) |
|
|
(41 |
) |
|
Net
loss |
|
$ |
(11,744 |
) |
|
$ |
(11,564 |
) |
|
$ |
(23,233 |
) |
|
$ |
(20,167 |
) |
|
Net loss
per share - basic and diluted |
|
$ |
(0.28 |
) |
|
$ |
(0.17 |
) |
|
$ |
(0.55 |
) |
|
$ |
(0.32 |
) |
|
Comprehensive loss |
|
$ |
(11,726 |
) |
|
$ |
(11,520 |
) |
|
$ |
(23,227 |
) |
|
$ |
(20,137 |
) |
|
Weighted
average number of common shares used in net loss per share
calculation – basic and diluted |
|
|
42,503,584 |
|
|
|
69,712,883 |
|
|
|
42,469,337 |
|
|
|
62,397,454 |
|
|
|
|
Endocyte,
Inc.Balance Sheets(in thousands) |
|
|
|
|
|
As of December 31, |
|
|
As of June 30, |
|
|
|
2017 |
|
|
2018 |
|
|
|
|
|
|
(unaudited) |
|
Assets |
|
|
|
|
|
|
|
|
Cash, cash equivalents and investments |
|
$ |
97,471 |
|
|
$ |
166,793 |
|
Other assets |
|
|
3,291 |
|
|
|
5,376 |
|
Total
assets |
|
$ |
100,762 |
|
|
$ |
172,169 |
|
|
|
|
|
|
|
|
|
|
Liabilities
and stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
4,546 |
|
|
$ |
5,954 |
|
Deferred revenue, net of current portion |
|
|
732 |
|
|
|
349 |
|
Total stockholders’ equity |
|
|
95,484 |
|
|
|
165,866 |
|
Total
liabilities and stockholders’ equity |
|
$ |
100,762 |
|
|
$ |
172,169 |
|
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