Item 7.01 Regulation FD Disclosure.
Certain members of management of Neurotrope, Inc. (the "Company" or
"Neurotrope"), along with certain participants from Metuchen Pharmaceuticals,
L.L.C., held a conference call for investors on May 28, 2020 to discuss the
Company's new Phase 2 study to evaluate long-term therapeutic effect of
Bryostatin-1 for the treatment of patients with Alzheimer's Disease and the
Company's previously announced proposed merger with Metuchen Pharmaceuticals,
L.L.C. and contemplated spin-off. A copy of the transcript for the conference
call is attached hereto as Exhibit 99.1 and incorporated by reference herein.
The information set forth in this Item 7.01, including the exhibit attached
hereto, is intended to be furnished and shall not be deemed "filed" for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange
Act") or otherwise subject to the liabilities of that section, nor shall it be
deemed incorporated by reference in any filing under the Securities Act of 1933,
as amended, or the Exchange Act, except as expressly set forth by specific
reference in such filing.
Item 8.01 Other Events.
On May 28, 2020, the Company announced the launch of a new long-term Phase 2
clinical study of Bryostatin-1 for the treatment of patients with Alzheimer's
Disease. The new Phase 2 clinical study, which is expected to enroll
approximately 100 patients, will evaluate Bryostatin-1 in the absence of Namenda
for a 6-month period, which will include two 11-week dosing cycles. The study
will focus on AD patients with pre-specified moderately severe (Moderate
Stratum; MMSE-2 baseline score 14-10) and moderate (MMSE-2 baseline score 18-15)
disease, including a patient population that demonstrated the most evidence of
benefit in a prior study, and will focus on assessing sustained cognitive
benefit as measured by the Severe Impairment Battery (SIB) score, a widely
accepted measure of cognitive function in advanced dementia patients. This study
will be conducted in collaboration with the National Institutes of Health (NIH),
who granted the Company $2.7 million in funding to further investigate the
therapeutic effect of Bryostatin-1 in this patient population. Analysis of the
data will be conducted in consultation with Dr. Richard Thompson, Senior
Scientist from the Bloomberg School of Public Health at Johns Hopkins
University. The Company has engaged Worldwide Clinical Trials to initiate site
recruitment and activation. The Company expects to dose the first patient during
the late third quarter or early fourth quarter of this year.
Forward-Looking Statements
This communication contains forward-looking statements (including within the
meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and
Section 27A of the Securities Act of 1933, as amended) concerning Neurotrope,
Metuchen, the proposed transactions and other matters. These statements may
discuss goals, intentions and expectations as to future plans, trends, events,
results of operations or financial condition, or otherwise, based on current
beliefs of the management of Neurotrope, as well as assumptions made by, and
information currently available to, management. Forward-looking statements
generally include statements that are predictive in nature and depend upon or
refer to future events or conditions, and include words such as "may," "will,"
"should," "would," "expect," "anticipate," "plan," "likely," "believe,"
"estimate," "project," "intend," and other similar expressions. Statements that
are not historical facts are forward-looking statements. Forward-looking
statements are based on current beliefs and assumptions that are subject to
risks and uncertainties and are not guarantees of future performance. Actual
results could differ materially from those contained in any forward-looking
statement as a result of various factors, including, without limitation: the
risk that the conditions to the closing of the transactions are not satisfied,
including the failure to obtain stockholder approval for the transactions in a
timely manner or at all; uncertainties as to the timing of the consummation of
the Mergers and the Spin-Off and the ability of each of Petros, Neurotrope and
Metuchen to consummate the transactions; risks related to Petros' initial
listing on The Nasdaq Capital Market at the closing of the proposed transaction;
risks related to Neurotrope's ability to correctly estimate its operating
expenses and its expenses associated with the transaction; the ability of
Neurotrope or Metuchen to protect their respective intellectual property rights;
competitive responses to the transaction; unexpected costs, charges or expenses
resulting from the transaction; potential adverse reactions or changes to
business relationships resulting from the announcement or completion of the
transaction; and legislative, regulatory, political and economic developments.
The foregoing review of important factors that could cause actual events to
differ from expectations should not be construed as exhaustive and should be
read in conjunction with statements that are included herein and elsewhere,
including the risk factors included in Neurotrope's most recent Annual Report on
Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed
with the SEC. Neurotrope can give no assurance that the conditions to the
transaction will be satisfied. Except as required by applicable law, Neurotrope
undertakes no obligation to revise or update any forward-looking statement, or
to make any other forward-looking statements, whether as a result of new
information, future events or otherwise.
No Offer or Solicitation
This communication is not intended to and does not constitute an offer to sell
or the solicitation of an offer to subscribe for or buy or an invitation to
purchase or subscribe for any securities or the solicitation of any vote in any
jurisdiction pursuant to the proposed transaction or otherwise, nor shall there
be any sale, issuance or transfer of securities in any jurisdiction in
contravention of applicable law. No offer of securities shall be made except by
means of a prospectus meeting the requirements of the Securities Act of 1933, as
amended. Subject to certain exceptions to be approved by the relevant regulators
or certain facts to be ascertained, the public offer will not be made directly
or indirectly, in or into any jurisdiction where to do so would constitute a
violation of the laws of such jurisdiction, or by use of the mails or by any
means or instrumentality (including without limitation, facsimile transmission,
telephone and the internet) of interstate or foreign commerce, or any facility
of a national securities exchange, of any such jurisdiction.
Important Additional Information Will be Filed with the SEC
In connection with the proposed transaction among 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. NEUROTROPE URGES INVESTORS AND STOCKHOLDERS TO READ THESE MATERIALS
CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL
CONTAIN IMPORTANT INFORMATION ABOUT PETROS, NEUROTROPE, METUCHEN, THE PROPOSED
TRANSACTIONS AND RELATED MATTERS. Investors and shareholders will be able to
obtain free copies of the proxy statement, prospectus and other documents filed
by Petros and Neurotrope with the SEC (when they become available) through the
website maintained by the SEC at www.sec.gov. In addition, investors and
shareholders will be able to obtain free copies of the proxy statement,
prospectus and other documents filed by Petros and Neurotrope with the SEC by
contacting Investor Relations by mail at Neurotrope, Inc., Attn: Investor
Relations, 1185 Avenue of the Americas, 3rd Floor, New York, New York 10036.
Investors and stockholders are urged to read the proxy statement, prospectus and
the other relevant materials when they become available before making any voting
or investment decision with respect to the proposed transaction.
Participants in the Solicitation
Petros, Neurotrope and Metuchen, and each of their respective directors and
executive officers and certain of their other members of management and
employees, may be deemed to be participants in the solicitation of proxies in
connection with the proposed transaction. Information about Neurotrope's
directors and executive officers is included in Neurotrope's Annual Report on
Form 10-K for the year ended December 31, 2019, filed with the SEC on March 13,
2020. Additional information regarding these persons and their interests in the
transaction will be included in the proxy statement relating to the transactions
when it is filed with the SEC. These documents can be obtained free of charge
from the sources indicated above.
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