Midatech Pharma : Description Report of Foreign Issuer

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 OF THE

SECURITIES EXCHANGE ACT OF 1934

For the month of, January 2019 Commission File Number 001-37652

Midatech Pharma PLC

(Translation of registrant's name into English)

65 Innovation Drive

Milton Park

Abingdon, Oxfordshire, OX14 4RQ, United Kingdom

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F: Form 20-F x Form 40-F o

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o

SUBMITTED HEREWITH

Attached to the Registrant's Form 6-K filing for the month of January 2019, and incorporated by reference herein, is:

Exhibit No.

Description

99.1

Press release, dated January 25, 2019 entitled "Midatech receives FDA feedback on clinical plan for MTD201."

SIGNATURE

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, thereunto duly authorized.

Date: January 25, 2019

Midatech Pharma PLC

By:

/s/ Nicholas Robbins-Cherry

Nicholas Robbins-Cherry Chief Financial Officer

Exhibit IndexExhibit No.

Description

99.1

Press release, dated January 25, 2019 entitled "Midatech receives FDA feedback on clinical plan for MTD201."

Exhibit 99.1

25 January 2019

Midatech Pharma PLC ("Midatech", "Company" or "Group")

Midatech receives FDA feedback on clinical plan for MTD201

Midatech Pharma (AIM: MTPH, Nasdaq: MTP), the R&D company focused on delivering innovative oncology and rare disease products to patients, is pleased to announce that further to its announcement on 20 December 2018 (the "Update Announcement") it has received feedback from the FDA on the regulatory study for its lead product MTD201 Q-Octreotide.

The scenarios outlined for MTD201 in the Update Announcement included:

• 1. Single dose pharmacodynamic study in healthy volunteers

• 2. Multi dose study in healthy volunteers

• 3. Study in patients

The FDA feedback received indicates that Scenario 1 a single dose pharmacodynamic study in healthy volunteers would not support a new drug application. With this regulatory guidance the Company will now focus on Scenario 2. and 3. to determine the optimal study design for this final phase of the development of MTD201 to either establish equivalence of MTD201 versus Novartis' Sandostatin LAR ("SLAR"), or, the development of a differentiated product with an improved clinical profile. This could therefore include a multi dose study in healthy volunteers (Scenario 2), or a study in patients (Scenario 3). The final study protocol will be subject to the customary regulatory approvals.

The MTD201 exploratory study conducted in 2018 has shown MTD201 to have a number of competitive advantages over SLAR, including smaller needle size, simpler and more reliable reconstitution and injection, reduced wastage and significantly lower manufacturing costs. The Q-Sphera technology used in MTD201 has patent protection through into the 2030s.

Regulatory marketing authorisation submissions are currently planned for 2021 based on the Company's commercial manufacturing plan, and the Company expects to generate the required clinical data within this timeframe.

With regards to the Company's cash position and further to the Update Announcement, the Company has very limited cash to enable it to continue as a going concern. Following this announcement, the Company will urgently look to conclude its discussions with the potential strategic investor described in the Update Announcement. There is no guarantee that the Company will be able to conclude these funding discussions on terms or quantum similar to those outlined in the Update Announcement or at all. Further announcements will be made as appropriate.

Commenting on the announcement, Dr Craig Cook, Chief Executive Office of Midatech Pharma, said : "We are pleased to receive clarity from the regulator on the development path for our lead product MTD201 and we are excited by the prospects of the MTD201 program, as well as the Q-Sphera platform. With the feedback from the FDA now in hand, we are in a position to finalise the advancement plan for the program as we look to capture a share of the multibillion dollar sustained-release treatment opportunities. We look forward to updating the market on our funding and our development plans."

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF THE MARKET ABUSE REGULATION (EU) NO. 596/2014.