NEW YORK, June 10, 2020 /PRNewswire/ -- Neurotrope,
Inc. (Nasdaq: NTRP) ("Neurotrope" or the "Company") today announced
its entry into a strategic agreement with BryoLogyx Inc.,
www.BryoLogyx.com, for the supply of synthetic, GMP-certified
Bryostatin-1, manufactured by Albany Molecular Research, Inc.
("AMRI"), a leading global CDMO provider of advanced drug
development and manufacturing solutions. Neurotrope
expects to use the synthetic Bryostatin-1 in its clinical
development initiatives aimed at advancing its lead product
candidate for the treatment of Alzheimer's disease ("AD") and other
neurodegenerative diseases and, ultimately, as a source for
potential commercial drug supply if regulatory approval is
received.
"This strategic partnership with BryoLogyx brings to Neurotrope
the first fully synthetic, scalable source of Bryostatin-1,
providing a clinical supply for the Company's planned Phase 3 study
and a manufacturing alternative
that delivers a dramatically superior cost of goods," stated Dr.
Daniel Alkon, President and Chief
Scientific Officer of Neurotrope. "Having better ongoing access to
Bryostatin-1 drug supply is expected to have a positive impact on
our future development efforts and, ultimately, our potential
commercialization efforts if regulatory approval is received.
Neurotrope has an exclusive license agreement with Stanford University for the use of this synthetic
Bryostatin-1 in the treatment of all neurological disorders.
In addition, BryoLogyx's innovation-driven work utilizing
bryostatins for use in cancer immunotherapy make them an ideal
partner to continue advancement of the CD22+ B-cell acute
lymphoblastic leukemia ("ALL") development program, where they have
the expertise and resources to realize its full potential."
Under the terms of the agreement, BryoLogyx will supply
Neurotrope with specified amounts of synthetic, GMP-grade
Bryostatin-1., manufactured by AMRI Group. BryoLogyx will pay
a fee on gross revenues generated by the commercial sale of
Bryostatin-1 product sold by BryoLogyx for the treatment of
ALL. In exchange, Neurotrope will transfer to BryoLogyx the
program right to develop Bryostatin-1 with CAR-T therapy for the
potential treatment of CD22+ B-cell ALL with the National Cancer
Institute. Relapsed ALL in CD22 CAR-T treated patients has been
associated with reduced CD22 antigen density. Bryostatin-1 has been
shown to increase CD22 expression levels, resulting in improved
durability of chimeric antigen receptor ("CAR") response.
Neurotrope will also transfer to BryoLogyx the Investigational New
Drug ("IND") application that is in development, as well as its
Cooperative Research and Development Agreement ("CRADA") with the
NCI under which Bryostatin-1's ability to modulate CD22 in patients
with relapsed/refractory CD22+ disease has been evaluated to
date. BryoLogyx will be responsible for the IND and CRADA
going forward.
As recently announced, Neurotrope has entered into a definitive
merger agreement pursuant to which Metuchen Pharmaceuticals, L.L.C.
and Neurotrope have agreed to merge in an all-stock transaction
resulting in a newly formed holding company focused on men's health
conditions, which will be named Petros Pharmaceuticals, Inc.
("Petros"). Upon closing of the transaction, Bryostatin-1 and
substantially all of Neurotrope's existing assets, operations and
liabilities, except for cash retained by Petros in accordance with
the terms of the merger agreement, will be spun-out into a new,
separately traded company which will retain the name Neurotrope
Bioscience, Inc. ("NBI").
Dr. Charles S. Ryan, Neurotrope's
Chief Executive Officer, added: "As we continue to work toward
completing our agreement with Metuchen Pharmaceuticals and offer
Neurotrope stakeholders pro-rata ownership in two distinct
investment opportunities, we are pleased to have access to
synthetic bryostatin. This agreement further underscores the
long-term potential of both NBI and Petros as distinct, standalone,
publicly-traded companies in two areas of high unmet medical need
in the life sciences."
About Neurotrope, Inc.
Neurotrope is a clinical-stage biopharmaceutical company working
to develop novel therapies for neurodegenerative diseases.
Neurotrope has conducted clinical and preclinical studies of its
lead therapeutic candidate, Bryostatin-1, in Alzheimer's disease,
and preclinical studies for rare diseases and brain injury,
including Fragile X syndrome, multiple sclerosis, stroke,
Niemann-Pick Type C disease, Rett syndrome, and traumatic brain
injury. The FDA has granted Orphan Drug Designation to Neurotrope
for Bryostatin-1 as a treatment for Fragile X syndrome.
Bryostatin-1 has already undergone testing in more than 1,500
people in cancer studies, thus creating a large safety data base
that will further inform clinical trial designs.
Neurotrope has entered into a definitive merger agreement
pursuant to which Metuchen Pharmaceuticals, L.L.C. and Neurotrope
have agreed to merge in an all-stock transaction resulting in a
newly formed holding company focused on men's health conditions,
which will be named Petros Pharmaceuticals, Inc. ("Petros").
Upon closing of the transaction, Bryostatin-1 and substantially all
of NBI's existing assets, operations and liabilities, except for
cash retained by Petros in accordance with the terms of the merger
agreement, will be spun-out into a new, separately traded company
named Neurotrope Bioscience, Inc.
Additional information about Neurotrope may be found on its
website: www.neurotrope.com.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No public offer of
securities shall be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act of 1933, as
amended.
Important Additional Information Will be Filed with the
SEC
In connection with the proposed transaction between Petros,
Neurotrope and Metuchen, Petros intends to file relevant materials
with the SEC, including a registration statement that will contain
a proxy statement and prospectus. BEFORE MAKING ANY VOTING OR
INVESTMENT DECISION, INVESTORS AND STOCKHOLDERS ARE URGED TO READ
THE PROXY STATEMENT/PROSPECTUS (INCLUDING ANY AMENDMENTS OR
SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT
NEUROTROPE MAY FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE
THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
TRANSACTIONS. Stockholders may obtain, free of charge, copies of
the definitive proxy statement/prospectus and any other documents
filed by Petros with the SEC in connection with the proposed
transactions at the SEC's website (www.sec.gov), at Neurotrope's
website: www.neurotrope.com, or by directing written request to:
Neurotrope, Inc., 1185 Avenue of the Americas, 3rd Floor,
New York, New York 10036,
Attention: Robert Weinstein.
Participants in the Solicitation
Petros, Neurotrope, Metuchen and their respective directors and
executive officers may be deemed to be participants in the
solicitation of proxies from the stockholders of Neurotrope in
connection with the proposed transaction. Information regarding the
special interests of these directors and executive officers in the
merger will be included in the proxy statement/prospectus referred
to above. Additional information regarding the directors and
executive officers of Neurotrope is also included in Neurotrope's
Definitive Proxy Statement on Schedule 14A relating to the 2019
Annual Meeting of Stockholders, which was filed with the SEC on
June 5, 2019. This document is
available free of charge at the SEC web site (www.sec.gov), at
Neurotrope's website, or by directing a written request to
Neurotrope as described above.
Forward-Looking Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking
statements. These forward-looking statements include statements
regarding Petros, Neurotrope, Metuchen, the combined company, the
proposed merger transaction, spin-off and other related matters,
the Phase 2 study and further studies, and continued development of
use of Bryostatin-1 for AD and other cognitive diseases. Such
forward-looking statements are subject to risks and uncertainties
and other influences, many of which the Company has no control
over. There can be no assurance that the Company will be able to
complete the merger transaction with Metuchen or realize the
expected benefits from such transaction, the clinical program for
Bryostatin-1 will be successful in demonstrating safety and/or
efficacy, that we will not encounter problems or delays in clinical
development, or that Bryostatin-1 will ever receive regulatory
approval or be successfully commercialized. Actual results and the
timing of certain events and circumstances may differ materially
from those described by the forward-looking statements as a result
of these risks and uncertainties. Additional factors that may
influence or cause actual results to differ materially from
expected or desired results may include, without limitation, the
risk that the conditions to the closing of the proposed
transactions are not satisfied, including the failure to obtain
stockholder approval for the proposed transactions in a timely
manner or at all, uncertainties as to the timing of the
consummation of the proposed transactions and the ability of each
of Petros, Neurotrope and Metuchen to consummate the proposed
transactions, the Company's inability to obtain adequate financing,
the significant length of time associated with drug development and
related insufficient cash flows and resulting illiquidity, the
Company's patent portfolio, the Company's inability to expand its
business, significant government regulation of pharmaceuticals and
the healthcare industry, lack of product diversification,
availability of the Company's raw materials, existing or increased
competition, stock volatility and illiquidity, and the Company's
failure to implement its business plans or strategies. These and
other factors are identified and described in more detail in the
Company's filings with the Securities and Exchange Commission,
including the Company's Annual Report on Form 10-K for the year
ended December 31, 2019 and the
Company's Current Report on Form 8-K filed on May 18, 2020. The Company does not undertake to
update these forward-looking statements.
Contacts
Corporate:
Robert Weinstein
Chief Financial Officer
973.242.0005 ext. 101 | rweinstein@neurotrope.com
Investors and Media:
Lisa Sher
Argot Partners
212.600.1902 | lisa@argotpartners.com
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SOURCE Neurotrope, Inc.