UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of Earliest Event Reported):
PROTAGENIC THERAPEUTICS, INC.
(Exact name of Company as specified in its charter)
| (State
or other jurisdiction of incorporation) |
(Commission
File Number) |
(I.R.S.
Employer Identification No.) |
| (Address of principal executive offices) | (Zip Code) |
| (Company’s telephone number, including area code) |
| (Former name or former address, if changed since last report) |
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:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
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.
| Exhibit No. |
Description | |
| 99.1 | Press release – “Protagenic Therapeutics Announces Second Quarter 2021 Results and Provides Business Update” | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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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.
| PROTAGENIC THERAPEUTICS, INC. | ||
| Date: August 18, 2021 | By: | /s/ Alexander K. Arrow |
| Name: | Alexander K. Arrow | |
| Title: | Chief Financial Officer | |
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