Current Report Filing (8-k)
August 19 2021 - 6:02AM
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date
of Report (Date of Earliest Event Reported): August 17, 2021
PROTAGENIC
THERAPEUTICS, INC.
(Exact
name of Company as specified in its charter)
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Delaware
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000-51353
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06-1390025
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(State
or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S.
Employer
Identification No.)
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149
Fifth Avenue, Suite 500, New York, NY
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10010
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(Address
of principal executive offices)
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(Zip
Code)
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212-994-8200
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(Company’s
telephone number, including area code)
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|
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(Former
name or former address, if changed since last report)
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Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Company under any
of the following provisions:
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☐
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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☐
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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☐
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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☐
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities
registered pursuant to Section 12(b) of the Act:
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Title
of each class
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Trading
Symbol(s)
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Name
of each exchange on which registered
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Protagenic
Therapeutics, Inc. Common Stock
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PTIX
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Nasdaq
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Protagenic
Therapeutics, Inc. Common Stock Warrants
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PTIXW
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Nasdaq
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Item
7.01. Regulation FD.
The
company’s press release announcing Second Quarter 2021 results and providing a business update, which also included changes in
the timeline of initiation of the clinical trial of its lead drug candidate, PT00114, is furnished hereto as Exhibit 99.1.
The
information in this Form 8-K (including the Exhibit) shall not be deemed “filed” for purposes of Section 18 of the Securities
Exchange Act of 1934 (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 referenced in such a filing.
Item
8.01. Other Events.
As
previously announced, upon review of the company’s investigational new drug (IND) application filed on June 29, 2021, the U.S.
Food and Drug Administration (FDA) requested that the company provide clinical sites with ready-to-inject clinical vials rather than
providing site pharmacies with the drug substance to be formulated locally. Following the FDA’s request, the company immediately
began implementing this required change. As a result of this development, the company has revised its anticipated upcoming milestones
as outlined in its 2Q 2021 earnings release, issued yesterday:
Q4
2021: Re-filing of IND application for PT00114
Q1
2022: Initiation of Phase I/IIa study for PT00114
1H
2022: Initial Data Readout of Phase I/IIa study
Item
9.01. Financial Statements and Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
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PROTAGENIC
THERAPEUTICS, INC.
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Date:
August 18, 2021
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By:
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/s/
Alexander K. Arrow
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Name:
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Alexander
K. Arrow
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Title:
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Chief
Financial Officer
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