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)

January 26, 2022

 

 

ONCOTELIC THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware		000-21990		13-3679168
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

 

29397 Agoura Road, Suite 107

Agoura Hills, CA 91301

(Address of principal executive offices and Zip Code)

 

Registrant’s telephone number, including area code

(650) 635-7000

 

Not applicable.

(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 registrant under any of the following provisions (see General Instruction A.2. below):

 

☐	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 class		Trading Symbols		Name of each exchange on which registered
N/A		OTLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 7.01

Regulation FD Disclosure.

 

On January 26, 2021, Oncotelic Therapeutics, Inc. (the “Company”), began utilizing a new corporate presentation (the “Presentation”) regarding the Company’s biomarker program for OT-101 across multiple phase 2 trials in combination with pembrolizumab. Our phase 2 trials are designed to for the eventual approval of OT-101 against any solid tumors, with high-TGF signature, as determined by our companion diagnostic assay.

 

In June 2020, the Food and Drug Administration (the “FDA”) granted accelerated approval to pembrolizumab for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [ 10 mutations/megabase (mut/Mb)] solid tumors, as determined by a FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. We intend to utilize the same approval route for OT-101/ pembrolizumab combination.

 

A copy of the Presentation is attached hereto as Exhibit 99.1.

 

Disclaimer.

 

The information in this Current Report on Form 8-K, including the information set forth in Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), nor shall Exhibit 99.1 filed herewith be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Forward-Looking Statements.

 

This Current Report on Form 8-K may contain, among other things, certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, (i) statements with respect to the Company’s plans, objectives, expectations and intentions; and (ii) other statements identified by words such as “may”, “could”, “would”, should”, “believes”, “expects”, “anticipates”, “estimates”, “intends”, “plans” or similar expressions. Forward-looking statements in this document include, without limitation, statements regarding the Company’s expectations regarding the expectation and timing of AL-101’s approval through its proposed 505(b)(2) applications, whether the Company will complete development of AL-101, and the anticipated use of proceeds therefrom. These statements are based upon the current beliefs and expectations of the Company’s management and may be subject to significant risks and uncertainties; and that no assurances can be given that such expectations shall be fulfilled.

 

Item 9.01

Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.		Description		Incorporation by reference
99.1		Biomarker for Agnostic Approval		Filed herewith
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

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 hereunto duly authorized.

 

	Oncotelic Therapeutics, Inc.
Date: January 28, 2022	By:	/s/ Vuong Trieu
		Vuong Trieu
		Chief Executive Officer