- First Clinical Program in Fanconi Anemia
Demonstrating Early Hematological Stabilization in Patients -
- Additional First-in-human Results from up to
Three Programs Expected in 2018 -
Inotek Pharmaceuticals Corporation (NASDAQ: ITEK) today
announced the filing with the US Securities and Exchange Commission
(SEC) of the Company’s preliminary proxy statement in connection
with the previously announced proposed combination of Inotek
Pharmaceuticals and Rocket Pharmaceuticals, a leading US-based
multi-platform gene therapy company (the Merger).
“We believe the proposed merger with Rocket provides an
attractive opportunity for our shareholders,” said David P.
Southwell, President and Chief Executive Officer of Inotek. “Rocket
has several near-term clinical and proof of concept catalysts, a
well-funded operation and a management team with rare disease and
gene therapy leadership expertise.”
Key Rocket investment considerations:
- Rocket is the only gene therapy company
using a multi-platform approach leveraging the well-established
lentiviral vector (LVV) and adeno-associated viral vector (AAV)
gene delivery methods, enabling a broad range of first-in-class
indications to be carefully selected and pursued. Initial programs
are focused on developing treatments for devastating rare diseases
in children.
- Lead program, a Phase 1/2 LVV-based
gene therapy for Fanconi Anemia, is currently in clinical trials.
All patients treated on either Rocket LP-L01 or RP-L02 protocols
have had stable blood counts during the months subsequent to
investigational therapy, despite decreases noted during the months
and years preceding gene therapy.
- Three additional LVV-based programs are
advancing towards the clinic, including Leukocyte Adhesion
Deficiency-1, or LAD-I, Pyruvate Kinase Deficiency, or PKD, and
Infantile Malignant Osteopetrosis, or IMO.
- A fifth undisclosed AAV-based gene
therapy program is expected to enter the clinic next year and has
demonstrated encouraging histological correction of the disease
phenotype. This exciting program targets a monogenic pediatric
disease with early mortality and represents the first gene therapy
being developed for this large class of indications.
“We have built our pipeline applying stringent criteria. We
invest in validated assets with strong mechanistic rationale and
established preclinical proof of concept. We focus on rare,
untreated diseases where there is a high unmet need, with clear
clinical endpoints, and a well-defined regulatory pathway. With the
funding provided by the proposed merger with Inotek, we believe we
are well-positioned to achieve early clinical success and maintain
first-mover advantage in each of our exciting programs,” said
Gaurav Shah, M.D., Chief Executive Officer of Rocket.
Dr. Shah continued, “Preliminary results from our ongoing Phase
1/2 trial in Fanconi Anemia are encouraging, and we are seeing
early signs of in vivo engraftment and hematological stabilization
suggesting the potential for complete recovery of these patients
back to normal blood counts. With this merger, we look forward to
accelerating the advancement of our four other programs in LAD-I,
PKD, IMO and our AAV-based therapy, into the clinic.”
About the Proposed TransactionSubject to the terms of the
Merger Agreement, at the effective time of the Merger, shareholders
of Rocket will receive shares of newly issued Inotek common shares
in a private placement. Rocket shareholders are expected to own
approximately 81% of the combined Company and current Inotek
shareholders will own approximately 19% of the combined Company.
The percentage of the combined Company that Rocket’s shareholders
will own as of the close of the Merger is subject to adjustment
based on the amount of Inotek’s net cash at the closing date. The
Merger Agreement contains further details with respect to this
adjustment and the Merger. The Merger has been unanimously approved
by the Boards of Directors of both companies.
The Merger is subject to approval by Inotek stockholders and the
satisfaction of other customary closing conditions and is expected
to close in the first quarter of 2018.
Important Additional Information Has Been and Will be Filed
with the SECThis communication is being made in respect of the
Merger between Inotek and Rocket. The proposed Merger will be
submitted to the stockholders of Inotek for their consideration. In
connection with the Merger, Inotek has filed a preliminary proxy
statement with the SEC. A definitive proxy statement containing
information about the Merger will be mailed to each Inotek
stockholder entitled to vote at Inotek’s stockholder meeting.
INVESTORS AND STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT
AND ANY OTHER DOCUMENTS RELATING TO THE MERGER FILED OR TO BE FILED
WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY IF AND WHEN THEY
BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION
ABOUT INOTEK, ROCKET, AND THE MERGER AND RELATED MATTERS. Investors
and stockholders may obtain copies of the preliminary proxy
statement and all other documents filed with the SEC regarding the
Merger, free of charge, at the SEC's website (www.sec.gov).
Investors may also obtain these documents, free of charge, from
Inotek’s website (www.inotekpharma.com) under the link "Investors"
and then under the tab "SEC Filings."
Participants in SolicitationInotek, Rocket and their
respective directors and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders
of Inotek in connection with the Merger. Information about the
directors and executive officers of Inotek is set forth in Inotek’s
Form 10-K for the fiscal year ended December 31, 2016 and filed
with the SEC on March 16, 2017 and the proxy statement filed with
the SEC on April 26, 2017. Additional information regarding the
interests of these participants and other persons who may be deemed
participants in the Merger may be obtained by reading the proxy
statement regarding the Merger. Free copies of these documents may
be obtained from Inotek using the contact information below.
This document will not constitute an offer to sell or the
solicitation of an offer to buy any securities, nor will there be
any sale of securities in any jurisdiction in which such offer,
solicitation or sale would be unlawful prior to the registration or
qualification under the securities laws of any such
jurisdiction.
About Inotek Pharmaceuticals CorporationInotek
Pharmaceuticals is a biopharmaceutical company that was focused on
the discovery, development and commercialization of therapies for
ocular diseases, including glaucoma. For more information, please
visit www.inotekpharma.com. The inclusion of our website address
here and elsewhere in this press release does not include or
incorporate by reference the information on our website into this
press release.
About Rocket PharmaceuticalsRocket Pharmaceuticals is an
emerging, clinical-stage biotechnology company focused on
developing first-in-class gene therapy treatment options for rare,
undertreated diseases. Rocket’s multi-platform development approach
applies the well-established lentiviral vector (LVV) and
adeno-associated viral vector (AAV) gene therapy platforms.
Rocket's lead clinical program is a LVV-based gene therapy for the
treatment of Fanconi Anemia (FA), a difficult to treat genetic
disease that leads to bone marrow failure and potentially cancer.
Preclinical studies of additional bone marrow-derived disorders are
ongoing and target Pyruvate Kinase Deficiency (PKD), Leukocyte
Adhesion Deficiency-1 (LAD-I) and Infantile Malignant Osteopetrosis
(IMO). Rocket is also developing an AAV-based gene therapy program
for an undisclosed rare pediatric disease. Rocket is backed by
leading institutional investors, including RTW Investments,
Cormorant Asset Management and Tavistock Group. For more
information about Rocket, please visit www.rocketpharma.com.
Inotek Pharmaceuticals Corporation Forward-Looking
StatementsThis communication contains "forward-looking"
statements within the meaning of Section 21E of the Securities
Exchange Act of 1934, as amended, and the Private Securities
Litigation Reform Act of 1995, known as the PSLRA. These
statements, as they relate to stockholder votes for or against the
proposals set forth in the preliminary proxy statement, Inotek or
Rocket, the management of either such company or the proposed
transaction between Inotek and Rocket, involve risks and
uncertainties that may cause results to differ materially from
those set forth in the statements. These statements are based on
current plans, estimates and projections, and therefore, you are
cautioned not to place undue reliance on them. No forward-looking
statement can be guaranteed, and actual results may differ
materially from those projected. Inotek and Rocket undertake no
obligation to publicly update any forward-looking statement,
whether as a result of new information, future events or otherwise,
except to the extent required by law. Forward-looking statements
are not historical facts, but rather are based on current
expectations, estimates, assumptions and projections about the
business and future financial results of the pharmaceutical
industry, and other legal, regulatory and economic developments. We
use words such as "anticipates," "believes," "plans," "expects,"
"projects," "future," "intends," "may," "will," "should," "could,"
"estimates," "predicts," "potential," "continue," "guidance," and
similar expressions are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. Actual results could differ materially
from the results contemplated by these forward-looking statements
due to a number of factors, including, but not limited to, those
described in the documents Inotek has filed with the SEC as well as
the possibility that (1) the parties may be unable to obtain
stockholder or regulatory approvals required for the proposed
transaction or may be required to accept conditions that could
reduce the anticipated benefits of the Merger as a condition to
obtaining regulatory approvals; (2) the length of time necessary to
consummate the proposed transaction may be longer than anticipated;
(3) the parties may not be able to satisfy the conditions precedent
to consummate the proposed transaction; (4) the proposed
transaction may divert management's attention from Inotek's ongoing
business operations; (5) the anticipated benefits of the proposed
transaction might not be achieved; (6) Rocket's clinical programs
and pre-clinical studies may not be successful or completed on
time; (7) Rocket may not be able to successfully demonstrate safety
and efficacy of its clinical programs or pre-clinical studies; (8)
Rocket's expectations regarding the future development of its
clinical programs and pre-clinical studies may not materialize; (9)
Rocket's clinical programs may not obtain necessary regulatory or
other approvals; (10) Rocket's clinical programs may not meet proof
of concept; (11) Rocket may not be able to raise the necessary
capital to conduct Rocket's clinical programs and pre-clinical
studies or such capital may not be available; (12) the prospective
market size of Rocket's drug candidates may be different than
currently anticipated; (13) the proposed transaction may involve
unexpected costs; (14) the business may suffer as a result of
uncertainty surrounding the proposed transaction, including
difficulties in maintaining relationships with third parties or
retaining key employees; (15) the parties may be unable to meet
expectations regarding the timing, completion and accounting and
tax treatments of the transaction; (16) the parties may be subject
to risks related to the proposed transaction, including any legal
proceedings related to the proposed transaction and the general
risks associated with the respective businesses of Inotek and
Rocket, including the general volatility of the capital markets,
terms and deployment of capital, volatility of Inotek share prices,
changes in the biotechnology industry, interest rates or the
general economy, underperformance of Inotek's or Rocket's assets
and investments, decreased ability to raise funds and the degree
and nature of Inotek's and Rocket's competition, as well as the
risk that unexpected reductions in Inotek's cash balance could
adversely affect the portion of the combined company that the
Inotek stockholders retain; (17) activist investors might not
approve of the proposed transaction; or (18) the risks that are
more fully described in the section titled "Risk Factors" in
Inotek's most recent Quarterly Report on Form 10-Q and preliminary
proxy statement filed with the SEC, as well as subsequent and other
documents filed from time to time with the SEC by Inotek could
materialize. Additionally, forward-looking statements related to
Rocket's future expectations are subject to numerous risks and
uncertainties, including risks that planned development milestones
and timelines will not be met. Additional risks relating to
Rocket's business and operations are set forth in the proxy
statement that Inotek is filing to seek stockholder approval of the
Merger. Neither Inotek nor Rocket gives any assurance that either
Inotek or Rocket will achieve its expectations.
The foregoing list of factors is not exhaustive. You should
carefully consider the foregoing factors and the other risks and
uncertainties that affect the businesses of Inotek described in the
"Risk Factors" section of its Annual Report on Form 10-K, Quarterly
Reports on Form 10-Q, proxy statement and other documents filed by
Inotek from time to time with the SEC, as well as Risk Factors
relating to Rocket in the preliminary proxy statement and that will
be contained in the definitive proxy statement for the proposed
transaction between Inotek and Rocket. All forward-looking
statements included in this document are based upon information
available to Inotek and Rocket the date hereof, and neither Inotek
nor Rocket assumes any obligation to update or revise any such
forward-looking statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20171012006479/en/
Inotek Contact:Claudine Prowse, Ph.D.Vice President,
Corporate Development and IROcprowse@inotekpharma.comorInotek
Media & Investor Contact:Joe Rayne,
781-327-5610jrayne@inotekpharma.comorRocket
Contact:investors@rocketpharma.com
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