Entered into agreement and plan of merger
with Novartis AG for $2.1Billion
Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company
developing targeted therapeutics for personalized cancer treatment,
today announced financial results for the third quarter ended Sept.
30, 2018 and provided an operational update.
“177Lu-PSMA-617’s value as a potential treatment for patients
with mCRPC has been reinforced in both our regulatory interactions
and our entry into a merger agreement with Novartis AG, along with
our longstanding interactions with patients and physicians in the
prostate cancer community,” said Mike Sherman, president and CEO of
Endocyte. “The team at Endocyte has always been passionate about
developing innovative therapies to help change the treatment
landscape for cancer patients, and we look forward to being able to
leverage Novartis’ global expertise and commitment to help realize
this mission.”
Third Quarter and Recent Highlights
- Announced on October 18, 2018, our entry into an agreement and
plan of merger with Novartis AG (Novartis), subject to the terms
and conditions of which Novartis will acquire Endocyte for $24 per
share, or a total equity value of approximately $2.1 billion, in
cash. The merger price represents a premium of 54% to Endocyte’s
closing price of $15.56 on October 17, 2018.
- Announced FDA acceptance of radiographic progression free
survival (rPFS) as an alternative primary endpoint of the ongoing
phase 3 VISION trial to support the submission of a New Drug
Application (NDA) for full approval of 177Lu-PSMA-617 for the
treatment of metastatic castration-resistant prostate cancer
(mCRPC).
- Completed an underwritten registered public offering of
10,878,379 shares of its common stock, including full exercise of
the underwriters’ option to purchase additional shares of common
stock, raising aggregate net proceeds from the offering of $188.9
million.
- Presented pre-clinical data from the company’s chimeric antigen
receptor T-cell (CAR T) adaptor molecule (CAM) platform at CAR-TCR
Summit 2018.
Expected Upcoming Milestones
- Submission of an Investigational New Drug (IND) application for
a phase 1 trial of EC17/CAR T-cell therapy in patients with
osteosarcoma (4Q 2018).
- Completion of the proposed transaction between Endocyte and
Novartis expected in 1H 2019, subject to approval by Endocyte
stockholders, antitrust and regulatory approvals, and other
customary closing conditions.
- Analysis of rPFS in VISION trial (late 2019).
Third Quarter 2018 Financial Results
Endocyte reported a net loss of $12.6 million, or $0.17 per
basic and diluted share, for the third quarter of 2018, compared to
a net loss of $23.3 million, or $0.55 per basic and diluted share,
for the same period in 2017.
Research and development expenses were $8.9 million for the
third quarter of 2018, compared to $4.1 million for the same period
in 2017. The increase was primarily attributable to: an increase of
$4.5 million in expenses related to development of PSMA-617,
including expenses related to the phase 3 VISION trial; an increase
of $1.2 million in compensation expense, of which $0.4 million
related to stock-based compensation charges; and an increase of
$0.1 million related to the company’s EC17/CAR T-cell therapy
program. These increases were partially offset by a decrease of
$0.8 million in EC1169 trial expenses and a decrease of $0.2
million for general research.
General and administrative expenses were $4.8 million for the
third quarter of 2018, compared to $3.0 million for the same period
in 2017. The increase was primarily attributable to: an increase of
$0.8 million in compensation expense, of which $0.5 million related
to stock-based compensation charges; an increase of $0.6 million in
legal and professional fees; and an increase of $0.4 million in
other general and administrative fees.
In September 2017, the company recorded $16.5 million of
acquired in-process research and development (“IPR&D”) expenses
related to a development and license agreement with ABX GmbH that
granted the company exclusive worldwide rights to develop and
commercialize PSMA-617, including the product candidate known as
177Lu-PSMA-617. The company did not incur any IPR&D expenses in
the third quarter of 2018.
Cash, cash equivalents and investments were $344.2 million at
September 30, 2018, compared to $103.1 million at September 30,
2017, and $97.5 million at Dec. 31, 2017. Cash, cash equivalents
and investments of $344.2 million at September 30, 2018 included
$188.9 million of net proceeds from the public offering of
10,878,379 shares of the company’s common stock that closed in
September 2018.
Financial Expectations
The company anticipates its cash, cash equivalents and
investments balance at the end of 2018 to exceed $310 million.
Based on current operational assumptions, Endocyte believes it 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.
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 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.
Additional Information and Where to Find It
In connection with the proposed transaction between Endocyte,
Inc. (“Endocyte”) and Novartis AG (the “merger”), Endocyte has
filed and intends to file relevant materials with the Securities
and Exchange Commission (the “SEC”). Endocyte filed a preliminary
proxy statement with the SEC on October 31, 2018, and intends to
file a definitive proxy statement with the SEC. Following the
filing of the definitive proxy statement with the SEC, Endocyte
will mail definitive proxy materials to each stockholder entitled
to vote at the special meeting relating to the merger.
Stockholders are urged to carefully read the proxy
statement and any other proxy materials in their entirety
(including any amendments or supplements thereto) and any other
relevant documents that Endocyte will file with the SEC when they
become available because they will contain important
information. The proxy statement and other relevant
materials (when available), and any and all documents filed by
Endocyte with the SEC, may also be obtained for free at the SEC’s
website at www.sec.gov. In addition, stockholders may obtain free
copies of the documents filed with the SEC by Endocyte in the
“Investors & News” section of its website at www.endocyte.com,
or copies may be obtained, without charge, by directing a request
to Corporate Secretary, Endocyte, Inc., 8910 Purdue Road, Suite
250, Indianapolis, Indiana 46268 or by calling (765) 463-7175.
Participants in the Solicitation
Endocyte and its directors and executive officers may be deemed,
under SEC rules, to be participants in the solicitation of proxies
from Endocyte’s stockholders with respect to the merger.
Information regarding such individuals is set forth in Endocyte’s
Annual Report on Form 10-K for the year ended December 31, 2017,
which was filed with the SEC on February 27, 2018, and its
definitive proxy statement for its 2018 annual meeting of
stockholders, which was filed with the SEC on March 23, 2018.
Additional information regarding the interests of such individuals
in the merger is included in Endocyte’s preliminary proxy statement
filed with the SEC and will be included in the definitive proxy
statement relating to the merger when it is filed with the SEC.
These documents may be obtained free of charge from the SEC’s
website at www.sec.gov and 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 the merger,
future spending, future cash balances, future use of capital,
sufficiency of cash, the timing of initiation, enrollment, and
completion of clinical trials, the likelihood of success of
clinical trials and of regulatory approval for product candidates,
the timing of regulatory submissions for product candidates,
estimates of the market opportunity for 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 in support of
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 may be unable to obtain
stockholder approval as required for the merger; conditions to the
closing of the merger, including the obtaining of required
regulatory approvals, may not be satisfied; the merger may involve
unexpected costs, liabilities or delays; the business or stock
price of the company may suffer as a result of uncertainty
surrounding the merger; the outcome of legal proceedings related to
the merger; the company may be adversely affected by other
economic, business, and/or competitive factors; the occurrence of
any event, change or other circumstances that could give rise to
the termination of the merger agreement; the ability to recognize
benefits of the merger; risks that the merger disrupts current
plans and operations and the potential difficulties in employee
retention as a result of the merger; other risks to consummation of
the merger, including the risk that the merger will not be
consummated within the expected time period or at all; the company
or independent investigators may experience delays in the
initiation, availability of data from, or completion of clinical
trials and development programs (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 lack of safety and/or
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 related to the company’s
inability to maintain, protect and enhance its intellectual
property; risks related to costs associated with defending
intellectual property infringement and other claims; 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, supply chain
issues of any type, including timing of supply, projected cash
needs, projected timing of the use of cash, and expected future
revenues, operations, expenditures and cash position. More
information about the risks and uncertainties faced by Endocyte is
contained in the company’s periodic reports filed with the SEC.
Endocyte 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
Nine Months |
| |
Ended September
30, |
|
Ended September
30, |
| |
2017 |
|
|
2018 |
|
|
2017 |
|
|
2018 |
|
| Collaboration
revenue |
$ |
33 |
|
|
$ |
86 |
|
|
$ |
58 |
|
|
$ |
116 |
|
| Costs and
expenses: |
|
|
|
|
|
|
|
|
|
|
|
| Research
and development |
|
4,090 |
|
|
|
8,856 |
|
|
|
20,739 |
|
|
|
21,736 |
|
| General
and administrative |
|
3,011 |
|
|
|
4,789 |
|
|
|
10,062 |
|
|
|
13,198 |
|
| Acquired
in-process research and development |
|
16,493 |
|
|
|
- |
|
|
|
16,493 |
|
|
|
- |
|
| Total operating
expenses |
|
23,594 |
|
|
|
13,645 |
|
|
|
47,294 |
|
|
|
34,934 |
|
| Loss from
operations |
|
(23,561 |
) |
|
|
(13,559 |
) |
|
|
(47,236 |
) |
|
|
(34,818 |
) |
| Interest income,
net |
|
265 |
|
|
|
959 |
|
|
|
734 |
|
|
|
2,092 |
|
| Other income (expense),
net |
|
29 |
|
|
|
(8 |
) |
|
|
2 |
|
|
|
(49 |
) |
| Net loss |
$ |
(23,267 |
) |
|
$ |
(12,608 |
) |
|
$ |
(46,500 |
) |
|
$ |
(32,775 |
) |
| Net loss per share -
basic and diluted |
$ |
(0.55 |
) |
|
$ |
(0.17 |
) |
|
$ |
(1.09 |
) |
|
$ |
(0.50 |
) |
| Comprehensive loss |
$ |
(23,237 |
) |
|
$ |
(12,596 |
) |
|
$ |
(46,463 |
) |
|
$ |
(32,733 |
) |
| Weighted average number
of common shares used in net loss per share calculation – basic and
diluted |
|
42,636,567 |
|
|
|
72,043,113 |
|
|
|
42,525,693 |
|
|
|
65,648,006 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Endocyte, Inc. |
| Balance Sheets |
| (in thousands) |
| |
|
|
As of December 31, |
|
|
As of September 30, |
|
|
2017 |
|
|
2018 |
| |
|
|
|
(unaudited) |
| Assets |
|
|
|
|
|
|
| Cash,
cash equivalents and investments |
$ |
97,471 |
|
|
$ |
344,210 |
| Other
assets |
|
3,291 |
|
|
|
10,994 |
| Total assets |
$ |
100,762 |
|
|
$ |
355,204 |
| |
|
|
|
|
|
|
| Liabilities and
stockholders’ equity |
|
|
|
|
|
|
| Current
liabilities |
$ |
4,546 |
|
|
$ |
7,675 |
| Deferred
revenue, net of current portion |
|
732 |
|
|
|
332 |
| Total
stockholders’ equity |
|
95,484 |
|
|
|
347,197 |
| Total liabilities and
stockholders’ equity |
$ |
100,762 |
|
|
$ |
355,204 |
Endocyte, Inc. (delisted) (NASDAQ:ECYT)
過去 株価チャート
から 1 2025 まで 2 2025
Endocyte, Inc. (delisted) (NASDAQ:ECYT)
過去 株価チャート
から 2 2024 まで 2 2025
