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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